Latest Developments

Recent notable developments in cancer treatment, as short summaries grouped by cancer type and news type. Each summary is based on an official source (FDA, TİTCK, Official Gazette) or a study published in a peer-reviewed journal; the licence and reimbursement status in Turkey is stated separately.

Last updated: Sources reviewed by: Assoc. Prof. Dr. Ali Oğul48 summaries with sources

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Cancer type

News type

Showing 48 developments

  • FDA Approval

    New approvals and indication expansions granted by the US Food and Drug Administration (FDA).

  • Turkey Licence (TİTCK)

    Products newly licensed in the records of the Turkish Medicines and Medical Devices Agency (TİTCK).

  • SGK Reimbursement

    SUT amendments published in the Official Gazette and updates to the reimbursement list.

  • Promising Studies

    Study results published in peer-reviewed journals that are not yet approved or do not amount to a drug approval.

ESMO 2026

  • Promising Studies
  • Congress · ESMO 2026

Highlights from ESMO Congress 2026 (Madrid, 23–27 October)

Selected study results presented at the European Society for Medical Oncology (ESMO) congress that are relevant to patients. The congress ended on 27 October; five studies presented on 23–25 October were added on 28 October. A detailed summary of each study is in its card in the relevant cancer type section.

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  • Advanced/recurrent endometrial cancer (after platinum and immunotherapy): The antibody–drug conjugate sacituzumab tirumotecan reduced the risk of death by 32% compared with doxorubicin or paclitaxel; median survival 19.0 versus 12.1 months (TroFuse-005, interim analysis). The results were published in The Lancet on 26 October 2026.
  • dMMR advanced endometrial cancer (first line): Chemotherapy-free pembrolizumab reduced the risk of progression/death by 43% compared with carboplatin plus paclitaxel; overall survival data are not yet mature; the comparison was not made with chemotherapy plus immunotherapy (KEYNOTE-C93, interim analysis). The results were published in The Lancet on 26 October 2026.
  • EGFR-mutant, MET-overexpressing lung cancer (first line): adding savolitinib to osimertinib prolonged the time until the disease progressed; median 24.9 versus 13.8 months (SANOVO, conducted only in China).
  • HER2-positive breast cancer, progression only in the brain (after radiosurgery): In 47 patients who had tucatinib added to their current HER2 treatment, 59% had no progression in the brain at 18 months (BRIDGET, phase 2, no comparison group).
  • Relapsed/refractory osteosarcoma: The antibody–drug conjugate risvutatug rezetecan prolonged progression-free survival compared with gemcitabine plus docetaxel; median 5.5 versus 1.4 months; survival data are not yet mature (ARTEMIS-011, conducted only in China).

Presented 23–25 October; added 28 October

  • dMMR/MSI-H locally advanced rectal cancer: With dostarlimab alone, the tumour disappeared for 12 months in 68% of patients followed for at least 12 months (investigator assessment; currently 47% by independent review); no comparison group (AZUR-1, phase 2, interim analysis; accelerated approval in the USA).
  • High-risk HR+/HER2− early breast cancer: Adding 3 years of ribociclib to hormone therapy after surgery: 91.9% vs 89.7% alive at 6 years (about 19% lower risk of death; descriptive analysis) (NATALEE).
  • Resected biliary tract cancer: Gemcitabine + cisplatin after surgery numerically prolonged time without recurrence compared with capecitabine (median 2.14 vs 1.49 years), but the main statistical test did not reach the significance threshold (ACTICCA-1).
  • Oesophageal cancer, complete clinical response after chemoradiotherapy: With close surveillance instead of surgery, 5-year survival was not different (50% vs 54%) and 43% of patients were spared surgery; however, distant metastases were more frequent (46% vs 29%) (SANO).
  • MSI-H/dMMR metastatic colorectal cancer: With more than 5 years of follow-up, nivolumab + ipilimumab reduced the risk of death by 39% compared with nivolumab alone and by 63% compared with chemotherapy in the first line (CheckMate 8HW, final analysis).

These results are congress data; they do not imply an approved use. Treatment decisions are made individually at a multidisciplinary tumour board.

Status in Turkey: The licence and SGK reimbursement status in Turkey of each study is given in the relevant card, based on the TİTCK licensed products list (16.10.2026) and the SGK EK-4/A list (02.10.2026; 23.10.2026 for the cards added on 28 October).

Tumour-agnostic

    • FDA Approval
    • Tumour-agnostic (TMB-H solid tumours)

    Pembrolizumab receives traditional approval for tumour mutational burden-high solid tumours; threshold updated to ≥13 mutations/megabase

    The FDA granted traditional approval to pembrolizumab (intravenous) and to pembrolizumab with berahyaluronidase alfa (subcutaneous) for adult and paediatric patients with unresectable or metastatic tumour mutational burden-high (TMB-H) solid tumours that have progressed after prior treatment and who have no satisfactory alternative treatment options. The indication had held accelerated approval since 2020, with TMB-H defined as ≥10 mutations per megabase. The new decision narrows the TMB-H definition to ≥13 mutations/megabase, because efficacy could not be confirmed at values from 10 to below 13. TMB must be determined with an FDA-authorised test. The decision is based on the KEYNOTE-158 trial: in 220 patients with TMB ≥13 mutations/megabase, the objective response rate was 36%; in 58% of responding patients the response lasted at least 12 months. The safety profile was consistent with the known profile of pembrolizumab; warnings include immune-mediated adverse reactions and infusion-related reactions. Eligibility should be decided at the tumour board, considering the tumour type, prior treatments and molecular test results together.

    Status in Turkey: Pembrolizumab (intravenous form) is licensed in Turkey (TİTCK licence date 06.06.2016) and is on the SGK EK-4/A list dated 02.10.2026; reimbursement depends on the indication conditions in the SUT, and reimbursement status for the TMB-H indication has not been verified. The subcutaneous form (pembrolizumab and berahyaluronidase alfa) was not found on the TİTCK licensed products list dated 09.10.2026.

Lung Cancer

Lung Cancer developments page
    • Promising Studies
    • Congress · ESMO 2026
    • Lung Cancer

    In EGFR-mutant, MET-overexpressing advanced lung cancer, first-line savolitinib plus osimertinib prolonged disease control (SANOVO)

    In some lung cancers a change in the EGFR gene drives the disease, and it is treated with targeted drugs taken by mouth. In some of these tumours a protein called MET is also present in large amounts; this is associated with the development of drug resistance. In the phase 3 SANOVO trial conducted in China, 326 previously untreated patients with EGFR-mutant, MET-overexpressing disease were randomly assigned to osimertinib plus the MET-targeting drug savolitinib or to osimertinib plus placebo. In the group with the highest MET level, median time until the disease progressed was 24.8 versus 11.1 months (HR 0.45), and in all patients 24.9 versus 13.8 months (HR 0.56). Overall survival, a secondary endpoint, also favoured the combination (median 44.5 versus 34.9 months). Stopping treatment because of side effects was more frequent with the combination (14.8% versus 4.3%). Important limitations are that the trial included only Chinese patients and that the MET test requires a special staining method; this combination is not approved in Turkey for this use. Joint assessment by pathology, molecular testing and thoracic oncology teams is essential to identify suitable patients.

    These results are clinical trial data presented at a congress; they do not imply an approved use. Treatment decisions are made at a multidisciplinary tumour board, considering tumour type, stage, general health and previous treatments together.

    Status in Turkey: Osimertinib is licensed in Turkey (TİTCK licence date 25.12.2017) and is on the SGK EK-4/A list dated 02.10.2026; savolitinib is not on the TİTCK licensed products list dated 16.10.2026. There is no licence or SGK reimbursement in Turkey for this combination.

    • FDA Approval
    • Lung Cancer

    Sevabertinib receives FDA accelerated approval as first-line treatment in HER2-mutant lung cancer

    The US Food and Drug Administration (FDA) expanded the indication of sevabertinib, an oral kinase inhibitor. The new approval covers adults with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumour has an activating mutation in the HER2 (ERBB2) tyrosine kinase domain and who have not previously received systemic treatment. The drug had previously received accelerated approval for patients who had received at least one systemic therapy. The decision is based on the single-arm SOHO-01 trial: in 69 previously untreated patients the objective response rate was 75%; among responders, the response lasted at least 6 months in 73% and at least 12 months in 38%. Under accelerated approval, the benefit must be confirmed in confirmatory trials. The main warnings are diarrhoea, hepatotoxicity and interstitial lung disease.

    Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no product with sevabertinib.

    • Promising Studies
    • Lung Cancer

    Daraxonrasib in RAS-mutant lung cancer: early-phase study results published

    A phase 1–2 study published in the New England Journal of Medicine evaluated daraxonrasib, an oral RAS inhibitor, in previously treated patients with advanced non-small cell lung cancer carrying a RAS mutation. The investigators note that RAS mutations are among the most common driver alterations in this cancer. In the analysis of 136 patients, the objective response rate was reported as between 31% and 37% depending on the dose group. Grade 3 or higher adverse events occurred in 54% of patients; rash, diarrhoea, nausea and mouth sores were commonly reported. These findings are early-phase data without a control group. The phase 3 RASolve 301 trial (NCT06881784), comparing the drug with docetaxel, is ongoing. Daraxonrasib has been approved by the FDA only in pancreatic cancer; in lung cancer it is investigational.

    Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no product with daraxonrasib.

    • FDA Approval
    • Lung Cancer

    Zidesamtinib receives FDA approval in ROS1-positive lung cancer after prior ROS1 therapy

    The FDA approved zidesamtinib for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have previously received at least one ROS1 tyrosine kinase inhibitor (TKI). The assessment is based on 117 patients in the single-arm ARROS-1 trial; some of them had previously received lorlatinib, repotrectinib or taletrectinib. The overall response rate was 44%; among responders, the response lasted at least 6 months in 82% and at least 12 months in 69%. The response rate was 49% after a single ROS1 TKI and 38% after two or more ROS1 TKIs. Warnings on the label include central nervous system adverse reactions, QTc prolongation, pneumonitis and bone fractures. The approval defines a new option in ROS1-positive disease that has developed resistance to previous treatments.

    Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no product with zidesamtinib.

    • Turkey Licence (TİTCK)
    • Lung Cancer

    Selpercatinib, used in RET fusion-positive lung cancer, received marketing authorisation in Turkey

    According to the records of the Turkish Medicines and Medical Devices Agency (TİTCK), a product containing selpercatinib was licensed on 26.03.2026. According to the approved Summary of Product Characteristics (KÜB), the drug can be used as monotherapy in adults with RET gene fusion-positive, locally advanced or metastatic non-small cell lung cancer who have not previously received a RET inhibitor. The KÜB also lists some thyroid cancer indications with a RET alteration. Selpercatinib is an oral kinase inhibitor that targets the RET signalling pathway. For this reason, the RET fusion must be demonstrated in the tumour by molecular testing before a treatment decision. RET fusion occurs in a small proportion of non-small cell lung cancers. A licence is the prerequisite for the drug to be prescribed in Turkey; reimbursement is a separate process.

    Status in Turkey: The product containing selpercatinib is not on the SGK list of reimbursed medicines (EK-4/A, 02.10.2026); its reimbursement status has not yet been clarified.

    • SGK Reimbursement
    • Lung Cancer

    SGK reorganised the reimbursement conditions for immunotherapy in lung cancer

    With the Health Implementation Communiqué (SUT) amendment published in the Official Gazette of 10 July 2025 (no. 32952), the reimbursement conditions for immunotherapy drugs were consolidated in a new paragraph under article 4.2.14.C. One of the provisions notable for lung cancer defines the conditions for first-line use of pembrolizumab together with chemotherapy in metastatic non-small cell lung cancer with a PD-L1 level below 50%: with platinum and pemetrexed in the non-squamous type, and with carboplatin and paclitaxel in the squamous type. The same paragraph also contains conditions for lung cancer for nivolumab and durvalumab. These drugs are used in hospital with a health board report, valid for at most three months, that includes a medical oncology specialist. The provisions entered into force 10 working days after publication.

    Status in Turkey: A product containing pembrolizumab entered the SGK EK-4/A list on 26.07.2025. Whether an individual patient is covered is assessed by the treating oncology team.

Breast Cancer

Breast Cancer developments page
    • Promising Studies
    • Congress · ESMO 2026
    • Breast Cancer

    In HER2-positive breast cancer, adding tucatinib after radiosurgery for brain metastases supported intracranial disease control (BRIDGET, phase 2)

    In HER2-positive breast cancer, the disease can sometimes progress only in the brain while the rest of the body is under control. In this situation, radiation targeted at the lesions in the brain (stereotactic radiosurgery) is usually given and the current HER2 treatment is continued. In the phase 2 BRIDGET study, tucatinib, a HER2-targeted drug taken by mouth that can reach the brain, was added to the current treatment in 47 patients treated in this way. During about 20 months of follow-up, 36% of patients had renewed progression in the brain; at 18 months, 59% had no progression in the brain, and progression outside the brain occurred in only 2 patients. Side effects were mostly manageable; diarrhoea and liver values should be monitored closely. The study is small and has no comparison group; the results were compared with historical data, and a randomised trial is needed for definitive evidence. Decisions on brain metastases are made through joint assessment by medical oncology, radiation oncology, neurosurgery and radiology.

    These results are clinical trial data presented at a congress; they do not imply an approved use. Treatment decisions are made at a multidisciplinary tumour board, considering tumour type, stage, general health and previous treatments together.

    Status in Turkey: Tucatinib is licensed in Turkey (TİTCK licence date 24.12.2025) but is not on the SGK EK-4/A list dated 02.10.2026. There is no SGK reimbursement for this use; treatment options should be discussed with your doctor.

    • Promising Studies
    • Congress · ESMO 2026
    • Breast Cancer

    Adding ribociclib after surgery in high-risk HR-positive/HER2-negative early breast cancer: 6-year survival data (NATALEE)

    In hormone receptor-positive, HER2-negative early breast cancer, long-term hormone therapy is given after surgery; the phase 3 NATALEE trial studied adding oral ribociclib to this treatment in patients at high risk of recurrence. In the 6-year analysis of the trial, which included 5,101 patients with stage II–III disease, the risk of death was about 19% lower in the group given 3 years of ribociclib + an aromatase inhibitor than in the group given an aromatase inhibitor alone; the proportion alive at 6 years was 91.9% vs 89.7% (absolute difference 2.1%). The difference in time without recurrence also grew over time (83.2% vs 77.9% at 6 years). The benefit persisted even though patients had stopped the drug about 3 years earlier on average. No new safety concerns were reported. This survival analysis was prespecified but descriptive, and the absolute difference is small; the balance of benefit and side effects is assessed for each patient. Ribociclib is approved for this use in the USA and Europe; licensing and SGK reimbursement conditions in Turkey must be assessed separately. The post-surgery treatment plan is decided through joint assessment by medical oncology, surgical oncology, radiation oncology and pathology.

    These results are clinical trial data presented at a congress; they do not imply an approved use. Treatment decisions are made at a multidisciplinary tumour board, considering tumour type, stage, general health and previous treatments together.

    Status in Turkey: Ribociclib is licensed in Turkey (TİTCK licence date 11.05.2020) and is on the SGK EK-4/A list dated 23.10.2026; the aromatase inhibitors (letrozole, anastrozole) are also licensed and listed. The indication and reimbursement scope for post-surgery use in early-stage disease could not be verified.

    • FDA Approval
    • Breast Cancer

    Tucatinib received FDA approval as maintenance therapy in HER2-positive metastatic breast cancer

    The FDA approved tucatinib, together with trastuzumab and pertuzumab, as maintenance therapy after induction treatment in HER2-positive, unresectable locally advanced or metastatic breast cancer. The HER2CLIMB-05 trial enrolled 654 patients whose disease had not progressed after 4–8 cycles of trastuzumab, pertuzumab and a taxane; patients with brain metastases were also included. Median progression-free survival was 24.9 months in the tucatinib arm and 16.3 months in the placebo arm (hazard ratio 0.64). Overall survival data were not yet mature at the time of analysis. Patients with hormone receptor-positive disease could continue endocrine therapy. The label carries a boxed warning for hepatotoxicity; diarrhoea is also among the adverse effects requiring close monitoring.

    Status in Turkey: A product containing tucatinib appears to be licensed in the TİTCK list (licence date 24.12.2025) but is not on the SGK EK-4/A list; the licence and reimbursement status of maintenance use in Turkey has not yet been clarified.

    • SGK Reimbursement
    • Breast Cancer

    SGK updated the reimbursement conditions for trastuzumab emtansine and pertuzumab in HER2-positive breast cancer

    With the SUT amendment published in the Official Gazette of 2 October 2026 (no. 33388), the conditions for two treatments in HER2-positive breast cancer were rewritten. Trastuzumab emtansine can be used as adjuvant treatment, for up to 14 cycles, in early-stage patients who received at least 4 cycles of taxane and anti-HER2 therapy before surgery and who have invasive residual disease larger than 1 cm in the breast or in a lymph node after surgery. In metastatic disease it is used on progression after trastuzumab and a taxane. In combinations containing pertuzumab, preoperative use was limited to a maximum of 4 cycles; in metastatic disease it can be used first-line with docetaxel, and if docetaxel is discontinued because of side effects, trastuzumab and pertuzumab can be continued. These provisions enter into force 5 working days after publication.

    Status in Turkey: With the list annexed to the same Communiqué, the subcutaneous fixed-dose combination of pertuzumab and trastuzumab was added to the EK-4/A list. A health board report that includes a medical oncology specialist is required for prescription.

    • FDA Approval
    • Breast Cancer

    The combination of imlunestrant and abemaciclib received FDA approval for ESR1-mutated advanced breast cancer

    The FDA approved the use of imlunestrant, an oral oestrogen receptor antagonist, together with abemaciclib, a CDK4/6 inhibitor. The approval covers adults with oestrogen receptor-positive, HER2-negative, ESR1-mutated, locally advanced or metastatic breast cancer that has progressed after at least one line of endocrine therapy. The ESR1 mutation is determined from circulating tumour DNA in the blood with an FDA-authorised test; the FDA also approved the blood test that detects the mutation as a companion diagnostic. The decision is based on the open-label phase 3 EMBER-3 trial, in which 874 patients were randomised. In an exploratory subgroup analysis of 159 patients with an ESR1 mutation, median progression-free survival was 11.1 months in the combination arm and 5.5 months in the imlunestrant-only arm; response rates were 35% and 15%. At the interim analysis, overall survival data were not yet mature. According to the FDA, the benefit was seen only in patients with an ESR1 mutation. The abemaciclib label carries warnings for diarrhoea, neutropenia, interstitial lung disease or pneumonitis, hepatotoxicity and venous thromboembolism.

    Status in Turkey: The TİTCK list of licensed products dated 09.10.2026 contains no product with imlunestrant; abemaciclib appears to be licensed as a separate product. The current TİTCK list is being followed for the licence status of this combination in Turkey.

    • FDA Approval
    • Breast Cancer

    Switching to camizestrant on detection of an ESR1 mutation in breast cancer receives FDA accelerated approval

    The FDA granted accelerated approval to camizestrant for patients with hormone receptor-positive, HER2-negative advanced breast cancer in whom an ESR1 mutation is detected in the blood while on aromatase inhibitor and CDK4/6 inhibitor therapy. In this approach, when a mutation is detected by circulating tumour DNA testing, before the disease progresses on imaging, the aromatase inhibitor is stopped and camizestrant is started while the CDK4/6 inhibitor is continued. In the SERENA-6 trial, 315 patients were randomised; median progression-free survival was 16 months in the camizestrant arm and 9.2 months in the arm that continued the aromatase inhibitor (hazard ratio 0.44). A blood test was approved together with it as a companion diagnostic. Overall survival is an additional assessment measure; under accelerated approval, the benefit must be confirmed with confirmatory data.

    Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no product with camizestrant.

    • Turkey Licence (TİTCK)
    • Breast Cancer

    Two targeted drugs received marketing authorisation in Turkey for breast cancer with PIK3CA/AKT pathway alterations

    According to TİTCK records, two targeted drugs used in breast cancer were licensed in summer 2026. According to the KÜB, inavolisib (licence date 13.07.2026) can be used together with palbociclib and fulvestrant in adults with PIK3CA-mutated, oestrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer that recurred during or within 12 months after the end of adjuvant endocrine therapy. Capivasertib (licence date 31.07.2026) is licensed for use together with fulvestrant in oestrogen receptor-positive, HER2-negative advanced breast cancer with a PIK3CA, AKT1 or PTEN alteration, in patients whose disease progressed during or after aromatase inhibitor therapy. For both drugs, the relevant gene alteration must be demonstrated by a tumour or blood test.

    Status in Turkey: Neither drug is on the SGK EK-4/A list (02.10.2026); their reimbursement status has not yet been clarified.

Colorectal Cancer

Colorectal Cancer developments page
    • Promising Studies
    • Congress · ESMO 2026
    • Colorectal Cancer

    Dostarlimab alone led to a clinical complete response in a substantial proportion of patients with dMMR/MSI-H locally advanced rectal cancer (AZUR-1, phase 2)

    In a small proportion of rectal cancers, a defect in the DNA repair system (dMMR/MSI-H) makes the tumour highly sensitive to immunotherapy. In locally advanced disease the standard approach combines chemotherapy, radiotherapy and surgery, which can cause lasting problems with bowel, urinary and sexual function. In the international phase 2 AZUR-1 trial, 154 previously untreated patients received the immunotherapy drug dostarlimab alone for about 6 months. By investigator assessment, the tumour disappeared on examination and imaging in 68% of patients followed for at least 12 months, and this lasted at least 12 months; including complete responses in patients who had surgery, the rate was 76%. By independent central review the rate is currently 47% (the 12-month assessment is not yet complete for some patients). At about 26 months of follow-up, no recurrences were reported among patients with a complete response. Severe immune-related side effects occurred in a small number of patients. This is an interim analysis without a comparison group; long-term recurrence risk and quality-of-life data are not yet known. In the USA (FDA) this use has received accelerated approval; its licensing and reimbursement status in Europe and Turkey has not been verified. The tumour must first be shown to be dMMR/MSI-H with reliable tests. A decision to monitor without surgery requires joint assessment by medical oncology, general surgery, radiation oncology, gastroenterology (endoscopy), radiology and pathology, and regular close follow-up.

    These results are clinical trial data presented at a congress; they do not imply an approved use. Treatment decisions are made at a multidisciplinary tumour board, considering tumour type, stage, general health and previous treatments together.

    Status in Turkey: Dostarlimab is licensed in Turkey (TİTCK licence date 19.01.2026); it is not on the SGK EK-4/A list dated 23.10.2026. The indication and reimbursement status for this rectal cancer use could not be verified.

    • Promising Studies
    • Congress · ESMO 2026
    • Colorectal Cancer

    Nivolumab plus ipilimumab in MSI-H/dMMR metastatic colorectal cancer: final survival results after more than 5 years of follow-up (CheckMate 8HW)

    A small proportion of colorectal cancers (MSI-H/dMMR) are particularly sensitive to immunotherapy. The phase 3 CheckMate 8HW trial compared the combination of two immunotherapy drugs (nivolumab + ipilimumab) with nivolumab alone and with chemotherapy in this type of colorectal cancer that has spread (metastatic). In the final analysis, with median follow-up of more than 5.5 years, the combination reduced the risk of death by about 39% compared with nivolumab alone across all lines of treatment, and by about 63% compared with chemotherapy in the first line. In the first line, the survival difference between the combination and nivolumab alone favoured the combination but was not statistically significant. No new safety concerns were reported with long follow-up; the known side effects of immunotherapy require close monitoring. This treatment is approved in the USA (FDA) for this use; licensing and SGK reimbursement conditions in Turkey must be assessed separately. The tumour must first be shown to be MSI-H/dMMR with reliable tests. Treatment is chosen through joint assessment by medical oncology, surgery, radiology and pathology.

    These results are clinical trial data presented at a congress; they do not imply an approved use. Treatment decisions are made at a multidisciplinary tumour board, considering tumour type, stage, general health and previous treatments together.

    Status in Turkey: Nivolumab (TİTCK licence date 19.04.2017) and ipilimumab (05.06.2014) are licensed in Turkey and are on the SGK EK-4/A list dated 23.10.2026; reimbursement is limited to the conditions in the SUT. The indication and reimbursement scope of the combination in MSI-H/dMMR metastatic colorectal cancer could not be verified.

    • FDA Approval
    • Colorectal Cancer

    Dostarlimab received FDA accelerated approval for stage II–III MSI-H/dMMR locally advanced rectal cancer

    The FDA granted accelerated approval to dostarlimab alone for previously untreated stage II–III locally advanced rectal cancer that is microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR). The decision is based on the AZUR-1 trial: 154 patients received dostarlimab every three weeks for nine cycles; patients with a clinical complete response were followed without surgery, with close endoscopy and MRI monitoring. By independent central review, 47% had a complete response lasting at least 12 months and the objective response rate was 79%; 38 more patients were in complete response but had not yet reached 12 months of follow-up. 71% of patients were being followed without surgery, radiation or additional drug treatment and without disease progression. The FDA also reviewed a second, 50-patient trial in which the 12-month complete response rate was 93%. Accelerated approval depends on confirmation with longer follow-up that the results are sustained. Warnings include immune-mediated adverse reactions and infusion-related reactions. Eligibility is determined by MSI/MMR testing of tumour tissue; the decision should be made jointly by the surgeon, radiation oncologist and medical oncologist.

    Status in Turkey: Dostarlimab is licensed in Turkey (TİTCK licence date 19.01.2026); it is not on the SGK EK-4/A list dated 02.10.2026. The indication and reimbursement status of this rectal cancer use in Turkey has not yet been clarified.

    • FDA Approval
    • Colorectal Cancer

    Atezolizumab, together with adjuvant chemotherapy, received FDA approval for stage III dMMR colon cancer

    The FDA approved atezolizumab for use with a fluoropyrimidine and oxaliplatin in the postoperative (adjuvant) treatment of stage III colon cancer with mismatch repair deficiency (dMMR) whose tumour has been completely removed surgically. The decision is based on the ATOMIC trial: 712 patients were randomised to receive 12 cycles of mFOLFOX6 plus atezolizumab (followed by 6 months of atezolizumab alone) or mFOLFOX6 alone. The hazard ratio for disease-free survival was 0.50, which corresponds to roughly a halving of the risk of recurrence or death. Median values were not reached in either arm. dMMR status is determined by testing tumour tissue and is seen in a subgroup of stage III colon cancers. Warnings include immune-mediated adverse reactions.

    Status in Turkey: Atezolizumab is licensed in Turkey for other indications; the licence and reimbursement status of this adjuvant colon cancer use in Turkey has not yet been clarified.

    • FDA Approval
    • Colorectal Cancer

    Encorafenib combination converted to full approval in BRAF V600E-mutant metastatic colorectal cancer

    The FDA granted full (traditional) approval to encorafenib, together with cetuximab and fluorouracil-based chemotherapy, for use in BRAF V600E-mutant metastatic colorectal cancer. The combination had received accelerated approval with mFOLFOX6 in 2024. The decision is based on the BREAKWATER trial, which enrolled previously untreated patients. Median progression-free survival was 12.8 months in the encorafenib, cetuximab and mFOLFOX6 arm and 7.1 months in the standard chemotherapy arm (hazard ratio 0.53). Median overall survival was 30.3 and 15.1 months, respectively (hazard ratio 0.49). In the first 110 patients randomised in each arm, the objective response rate was 61% versus 40%. The BRAF V600E mutation occurs in a subgroup of metastatic colorectal cancers and is tested for by molecular testing at diagnosis.

    Status in Turkey: Encorafenib is licensed in Turkey (TİTCK, 2023) but is not on the SGK EK-4/A list; the reimbursement status of this use has not yet been clarified.

    • Promising Studies
    • Colorectal Cancer

    Low-dose aspirin reduced recurrence in colorectal cancer with PI3K pathway alterations

    The ALASCCA trial, published in the New England Journal of Medicine, compared 160 mg of aspirin daily for three years with placebo in patients with operated stage I–III rectal or stage II–III colon cancer whose tumour had an alteration in PI3K signalling pathway genes. The three-year recurrence rate was 7.7% with aspirin and 14.1% with placebo in the group with a PIK3CA hotspot mutation (hazard ratio 0.49). In the group with other PI3K alterations, the rates were 7.7% and 16.8% (hazard ratio 0.42). Serious adverse events occurred in 16.8% of the aspirin arm and 11.6% of the placebo arm. Although the results are promising, aspirin should not be started before it is reflected in guidelines and the individual bleeding risk has been assessed; this decision must always be made together with a physician.

    Status in Turkey: Aspirin is a licensed medicine in Turkey; however, its use to prevent recurrence in colorectal cancer is not an approved indication.

    • Promising Studies
    • Colorectal Cancer

    A structured exercise programme after chemotherapy prolonged disease-free survival in colon cancer

    In the phase 3 CHALLENGE trial published in the New England Journal of Medicine, 889 patients with colon cancer who had completed surgery and adjuvant chemotherapy were randomised to a three-year structured exercise programme or to a group receiving only health education material. At a median follow-up of 7.9 years, disease-free survival was longer in the exercise group (hazard ratio 0.72); five-year disease-free survival was 80.3% versus 73.9%. Overall survival findings also favoured the exercise group (hazard ratio 0.63; eight-year survival 90.3% versus 83.2%). Musculoskeletal adverse events were more common in the exercise group (18.5% versus 11.5%). This is not a drug approval; the study provides strong data that exercise can be a planned part of post-treatment care.

    Status in Turkey: This is not a matter of licensing or reimbursement; the appropriate level of exercise should be planned together with a physician and a physiotherapist.

Oesophageal Cancer

Stomach Cancer developments page
    • Promising Studies
    • Congress · ESMO 2026
    • Oesophageal Cancer

    Close surveillance instead of surgery in oesophageal cancer that disappears after chemoradiotherapy: 5-year results (SANO)

    In locally advanced oesophageal cancer, the standard approach is chemotherapy and radiotherapy before surgery (chemoradiotherapy) followed by removal of the oesophagus (oesophagectomy). In some patients the tumour disappears completely on examination and imaging after chemoradiotherapy. In the SANO trial, conducted in the Netherlands, 309 patients in this situation were directed either to close surveillance with regular endoscopy and PET-CT (with surgery if needed) or to standard surgery. At about 6 years of follow-up, the 5-year survival rate was 50% in the surveillance group and 54% in the surgery group, and the difference was not statistically significant. About 43% of patients in the surveillance group were spared surgery that would not have benefited them. On the other hand, spread to distant organs (metastasis) at 5 years was more frequent in the surveillance group (46% vs 29%); this is an important caution. These results suggest that close surveillance is a feasible strategy in selected patients, but it should be considered in experienced centres able to provide strict, regular follow-up, after detailed discussion with the patient. This decision requires joint assessment by medical oncology, surgery, radiation oncology, gastroenterology, nuclear medicine/radiology and pathology.

    These results are clinical trial data presented at a congress; they do not imply an approved use. Treatment decisions are made at a multidisciplinary tumour board, considering tumour type, stage, general health and previous treatments together.

    Status in Turkey: This is a treatment strategy study, not a drug study; drug licensing and SGK drug reimbursement do not apply. Whether close surveillance is feasible depends on the centre’s capacity for regular follow-up with endoscopy and PET-CT.

Gastric Cancer

Stomach Cancer developments page
    • FDA Approval
    • Gastric Cancer

    Zanidatamab combinations receive FDA approval in HER2-positive gastric and gastroesophageal junction cancer

    The FDA approved two first-line uses in HER2-positive, unresectable locally advanced or metastatic adenocarcinoma of the stomach, gastroesophageal junction and oesophagus: the triplet of zanidatamab, chemotherapy and tislelizumab (IHC 3+ or IHC 2+/ISH-positive) and the doublet of zanidatamab and chemotherapy (IHC 3+ only). In the three-arm HERIZON-GEA-01 trial, median overall survival was 26.4 months with the triplet combination and 19.2 months with trastuzumab and chemotherapy (hazard ratio 0.72). Median progression-free survival was 12.4 versus 8.1 months (hazard ratio 0.63). Zanidatamab is a bispecific antibody that binds to two separate regions of the HER2 receptor. Two diagnostic tests that determine HER2 status were also approved with the approval.

    Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no product with zanidatamab and tislelizumab.

    • FDA Approval
    • Gastric Cancer

    Durvalumab receives FDA approval for perioperative use with FLOT chemotherapy in resectable gastric cancer

    The FDA approved durvalumab with FLOT chemotherapy before and after surgery, followed by durvalumab alone, in resectable gastric or gastroesophageal junction adenocarcinoma. The MATTERHORN trial enrolled 948 previously untreated patients with stage II–IVA disease. The hazard ratio for event-free survival was 0.71 and for overall survival 0.78; median event-free survival was 32.8 months in the placebo and FLOT arm, while it had not yet been reached in the durvalumab arm. The pathological complete response rate, meaning no viable tumour remaining in the surgical specimen, was 19.2% versus 7.2%. The trial was not designed to measure separately the contribution of durvalumab in the pre- and postoperative periods. Warnings include immune-mediated adverse reactions.

    Status in Turkey: Durvalumab is licensed in Turkey for other indications; the licence and reimbursement status of this perioperative gastric cancer use in Turkey has not yet been clarified.

    • Promising Studies
    • Gastric Cancer

    Satri-cel, a Claudin18.2-targeted CAR-T therapy in advanced gastric cancer: randomised phase 2 results

    The randomised phase 2 CT041-ST-01 trial, conducted in China and published in The Lancet, compared the CAR-T cell therapy satri-cel with standard treatment chosen by the physician in patients with Claudin18.2-positive advanced gastric or gastroesophageal junction cancer resistant to at least two lines of treatment. In the 156-patient trial, median progression-free survival was 3.25 months with satri-cel and 1.77 months in the control group (hazard ratio 0.37). Adverse events were marked: grade 3 or higher adverse events occurred during treatment in 99% of patients receiving satri-cel. CAR-T therapy is prepared by reprogramming the patient’s own immune cells in the laboratory to recognise the tumour. There is no FDA approval for satri-cel; the treatment is investigational.

    Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no satri-cel; the treatment is investigational.

Pancreatic Cancer

Pancreatic Cancer developments page
    • FDA Approval
    • Pancreatic Cancer

    Daraxonrasib receives FDA approval in previously treated metastatic pancreatic cancer

    The FDA approved daraxonrasib, an oral drug targeting RAS proteins, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not suitable for multi-drug chemotherapy. In the RASolute 302 trial, 500 patients whose disease had progressed after one line of treatment were randomised to daraxonrasib or standard chemotherapy chosen by the physician. In the whole patient group, median overall survival was 13.2 versus 6.7 months (hazard ratio 0.40), median progression-free survival 7.2 versus 3.6 months (hazard ratio 0.49); the response rate was 30% versus 11%. Because a KRAS mutation is present in the great majority of pancreatic cancers, this result is considered important. Warnings include skin and oral adverse effects, diarrhoea and pneumonitis.

    Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no product with daraxonrasib.

    • FDA Approval
    • Pancreatic Cancer

    Tumour treating fields (TTFields) device receives FDA approval in locally advanced pancreatic cancer

    The FDA approved a device that applies low-intensity, alternating electric fields through electrodes placed on the skin of the abdomen, used together with gemcitabine and nab-paclitaxel chemotherapy in unresectable locally advanced pancreatic cancer. The approval is based on the phase 3 PANOVA-3 trial. According to results published in the Journal of Clinical Oncology, median overall survival was 16.2 months in the device and chemotherapy arm and 14.2 months in the chemotherapy-only arm (hazard ratio 0.82). Pain-free survival was 15.2 versus 9.1 months; no significant difference was seen in progression-free survival. Device-related skin adverse effects were reported in 76% of patients; most were mild or moderate, and grade 3 skin adverse effects occurred in 7.7%.

    Status in Turkey: The status of use and reimbursement of this device for pancreatic cancer in Turkey has not yet been clarified.

Prostate Cancer

Prostate Cancer developments page
    • FDA Approval
    • Prostate Cancer

    Talazoparib with enzalutamide receives FDA approval in hormone-sensitive metastatic prostate cancer with HRR gene mutations

    The FDA approved the PARP inhibitor talazoparib in combination with enzalutamide for adults with metastatic prostate cancer that is androgen pathway modulation-naïve or -sensitive and carries homologous recombination repair (HRR) gene mutations. Mutations are detected with an FDA-authorised test on tumour tissue or blood (circulating tumour DNA). In the TALAPRO-3 trial, 599 patients were randomised to enzalutamide plus either talazoparib or placebo; all patients continued androgen deprivation therapy. The hazard ratio for radiographic progression-free survival was 0.48; the median was not reached in the talazoparib arm and was 45.8 months in the placebo arm. Overall survival data are still immature. The label includes warnings on bone marrow suppression, myelodysplastic syndrome/acute myeloid leukaemia and embryo-foetal toxicity. The combination was previously approved (June 2023) for HRR-mutated metastatic castration-resistant prostate cancer; the new approval moves it to an earlier stage of the disease. Treatment decisions should take into account both the genetic test result and the patient’s overall condition.

    Status in Turkey: Talazoparib is licensed in Turkey (TİTCK list of licensed products, 16.10.2026); however, the prostate cancer indication in the approved KÜB (06.05.2026) is limited, in combination with enzalutamide, to BRCA1/2-mutated metastatic castration-resistant disease. The licence for this new use in hormone-sensitive disease in Turkey could not be verified. The SGK list of reimbursed medicines (EK-4/A, as of 23.10.2026) contains no product with talazoparib; reimbursement for this new use could not be verified.

    • FDA Approval
    • Prostate Cancer

    Lutetium-177 PSMA therapy receives FDA approval in PSMA-positive hormone-sensitive metastatic prostate cancer

    The FDA approved the radioligand therapy lutetium Lu 177 vipivotide tetraxetan, together with an androgen receptor pathway inhibitor (ARPI), for use in adults with PSMA-positive, hormone-sensitive metastatic prostate cancer. Patients are selected by PSMA PET imaging. In the PSMAddition trial, 1144 patients were randomised to six doses of radioligand therapy given every six weeks plus an ARPI, or an ARPI alone; all patients also received hormone-suppressing treatment. The hazard ratio for radiographic progression-free survival was 0.72; median values were not reached in either arm. Overall survival data are not yet mature. This drug had previously been approved in castration-resistant metastatic prostate cancer; the new approval moves the treatment to an earlier stage of the disease.

    Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no product with lutetium Lu 177 vipivotide tetraxetan.

    • FDA Approval
    • Prostate Cancer

    Capivasertib receives FDA approval in hormone-sensitive metastatic prostate cancer with PTEN deficiency

    The FDA approved capivasertib, an AKT inhibitor, together with abiraterone and prednisone for adults with hormone-sensitive metastatic prostate cancer with PTEN deficiency. PTEN deficiency is determined by an immunohistochemistry test on tumour tissue, and this test was approved as a companion diagnostic. In the CAPItello-281 trial, 1012 newly diagnosed patients were randomised to receive capivasertib or placebo in addition to abiraterone. Median radiographic progression-free survival was 33.2 versus 25.7 months (hazard ratio 0.81). Overall survival data were not mature at the time of analysis. Warnings include elevated blood glucose, diarrhoea and skin rash; monitoring blood glucose during treatment is important.

    Status in Turkey: Capivasertib was licensed in Turkey on 31.07.2026; however, the indication in the KÜB is limited to breast cancer. The licence and reimbursement status in prostate cancer in Turkey has not yet been clarified.

    • SGK Reimbursement
    • Prostate Cancer

    SGK expanded the reimbursement scope for abiraterone and darolutamide in prostate cancer

    With the SUT amendment published in the Official Gazette of 23 May 2026 (no. 33262), two new reimbursement conditions were defined in prostate cancer. Abiraterone, provided it has an indication approved by the Ministry of Health, will be reimbursed in non-metastatic high-risk prostate cancer unsuitable for surgery, together with radiotherapy and androgen deprivation therapy (ADT), for up to 2 years. High risk is defined by the presence of at least two of the following: lymph node involvement or clinical T3–T4 stage, a Gleason score of 8–10, and a PSA above 40 ng/ml. Darolutamide will be reimbursed when used with ADT in hormone-sensitive metastatic prostate cancer without visceral (internal organ) metastasis. The regulation entered into force 5 working days after publication.

    Status in Turkey: Products containing darolutamide and abiraterone are on the SGK EK-4/A list.

Ovarian Cancer

Ovarian Cancer developments page
    • Turkey Licence (TİTCK)
    • Ovarian Cancer

    Mirvetuximab soravtansine received marketing authorisation in Turkey for folate receptor alpha-positive, platinum-resistant ovarian cancer

    According to TİTCK records, a product containing mirvetuximab soravtansine was licensed on 31.07.2026. According to the KÜB, the drug can be used as monotherapy in adults with folate receptor alpha (FRα)-positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have previously received one to three systemic treatment regimens. It is not suitable for use in primary platinum-refractory patients. Mirvetuximab soravtansine is an antibody-drug conjugate formed by attaching a chemotherapy molecule to an antibody that binds FRα. For eligibility, FRα expression must be demonstrated in the tumour tissue by testing. The KÜB carries a special warning for ocular toxicity; eye examination and protective eye drops are recommended before and during treatment.

    Status in Turkey: Mirvetuximab soravtansine is not on the SGK EK-4/A list (02.10.2026); its reimbursement status has not yet been clarified.

    • FDA Approval
    • Ovarian Cancer

    Relacorilant receives FDA approval together with nab-paclitaxel in platinum-resistant ovarian cancer

    The FDA approved the glucocorticoid receptor antagonist relacorilant together with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three lines of systemic therapy, at least one of which included bevacizumab. In the ROSELLA trial, 381 patients were randomised to relacorilant plus nab-paclitaxel or nab-paclitaxel alone. Median progression-free survival was 6.5 versus 5.5 months (hazard ratio 0.70) and median overall survival 16 versus 11.9 months (hazard ratio 0.65). Because the drug reduces the effect of cortisone, it should not be used in patients who need to take a corticosteroid for a vital reason. Neutropenia and serious infections are among the main warnings.

    Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no product with relacorilant.

    • FDA Approval
    • Ovarian Cancer

    Pembrolizumab receives FDA approval together with paclitaxel in PD-L1-positive platinum-resistant ovarian cancer

    The FDA approved pembrolizumab together with paclitaxel (with or without bevacizumab) in platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer whose tumour expresses PD-L1 (CPS 1 or higher) and who have previously received one or two lines of treatment. The KEYNOTE-B96 trial enrolled 643 patients. In 466 PD-L1-positive patients, median progression-free survival was 8.3 versus 7.2 months (hazard ratio 0.72) and median overall survival 18.2 versus 14.0 months (hazard ratio 0.76). PD-L1 testing is done with an approved diagnostic kit. Because treatment options in platinum-resistant ovarian cancer are limited, this result showing a survival difference is noteworthy. Warnings include immune-mediated adverse reactions.

    Status in Turkey: Pembrolizumab is licensed in Turkey for other indications; the licence and reimbursement status of this ovarian cancer use in Turkey has not yet been clarified.

Endometrial Cancer

Endometrial Cancer developments page
    • Promising Studies
    • Congress · ESMO 2026
    • Endometrial Cancer

    Sacituzumab tirumotecan prolonged survival compared with chemotherapy in previously treated advanced endometrial cancer (TroFuse-005)

    When endometrial cancer (cancer of the lining of the uterus) is advanced or has recurred, options after platinum-containing chemotherapy and immunotherapy are limited. In the phase 3 TroFuse-005 trial, 776 patients whose disease had progressed after these treatments were randomly assigned to sacituzumab tirumotecan, an antibody–drug conjugate that targets the TROP2 protein on the surface of tumour cells, or to chemotherapy chosen by the physician (doxorubicin or paclitaxel). At the interim analysis the risk of death was reduced by 32%: median overall survival was 19.0 versus 12.1 months (HR 0.68). Median time until the disease progressed was 7.2 versus 3.9 months; tumour shrinkage was seen in 35.1% versus 17.3%. Serious (grade 3 or higher) treatment-related adverse events were more frequent with the drug (54.4% versus 41.4%); the most common was anaemia, and mouth sores and low blood counts are also side effects that need monitoring. Quality of life was maintained in both groups. This drug is not yet approved for this use; assessment requires gynaecological oncology, medical oncology, radiation oncology and pathology to work together.

    These results are clinical trial data presented at a congress; they do not imply an approved use. Treatment decisions are made at a multidisciplinary tumour board, considering tumour type, stage, general health and previous treatments together.

    Status in Turkey: No product containing sacituzumab tirumotecan is on the TİTCK licensed medicinal products list dated 16.10.2026 (sacituzumab govitecan on the list is a different drug). There is no licence or SGK reimbursement in Turkey for this use; treatment options should be discussed with your doctor.

    • Promising Studies
    • Congress · ESMO 2026
    • Endometrial Cancer

    In dMMR advanced endometrial cancer, chemotherapy-free first-line pembrolizumab prolonged disease control compared with chemotherapy (KEYNOTE-C93)

    In some endometrial cancers the system that repairs errors in DNA (mismatch repair, MMR) is deficient; this is called “dMMR” and is tested in pathology. These tumours respond better to immunotherapy. In the phase 3 KEYNOTE-C93 trial, 299 patients with advanced or recurrent dMMR endometrial cancer who had not yet been treated were randomly assigned to the immunotherapy drug pembrolizumab alone or to carboplatin plus paclitaxel chemotherapy. At the interim analysis the risk of progression or death was reduced by 43%: median time until the disease progressed was 38.2 versus 8.4 months (HR 0.57). Overall survival data are not yet mature; no significant difference has been shown. Serious (grade 3 or higher) treatment-related adverse events were less frequent with pembrolizumab (18.1% versus 50.7%), and quality of life in the first 12 weeks was better in the pembrolizumab group. An important note: the comparison was made with chemotherapy alone, not with the “chemotherapy plus immunotherapy” combination often used today. Who a chemotherapy-free option suits is decided jointly by gynaecological oncology, medical oncology and pathology, considering the dMMR result, the extent of the disease and the person’s general condition.

    These results are clinical trial data presented at a congress; they do not imply an approved use. Treatment decisions are made at a multidisciplinary tumour board, considering tumour type, stage, general health and previous treatments together.

    Status in Turkey: Pembrolizumab is licensed in Turkey (TİTCK licence date 06.06.2016) and is on the SGK EK-4/A list dated 02.10.2026; reimbursement depends on the indication conditions in the SUT. Reimbursement coverage for first-line use alone in endometrial cancer could not be verified; treatment options should be discussed with your doctor.

Kidney Cancer

Kidney Cancer developments page
    • FDA Approval
    • Kidney Cancer

    The combination of belzutifan and lenvatinib received FDA approval for kidney cancer that progressed after immunotherapy

    The FDA approved the HIF-2α inhibitor belzutifan together with lenvatinib for use in advanced renal cell carcinoma with a clear cell component that has progressed after a PD-1 or PD-L1 inhibitor. In the LITESPARK-011 trial, 747 patients were randomised to this combination or to cabozantinib. Median progression-free survival was 14.6 versus 10.6 months (hazard ratio 0.74) and the objective response rate 53% versus 40%. In the final analysis of overall survival, however, no statistically significant difference could be shown (33.7 versus 28.6 months; hazard ratio 0.85). Belzutifan carries a boxed warning on harm to the fetus in pregnancy; anaemia and low oxygen levels (hypoxia) are among the adverse effects to be monitored.

    Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no product with belzutifan.

    • FDA Approval
    • Kidney Cancer

    Belzutifan and pembrolizumab combination receives FDA approval after surgery in kidney cancer

    The FDA approved the combination of belzutifan and pembrolizumab as adjuvant (postoperative protective) treatment in renal cell carcinoma with a clear cell component in patients at intermediate-high or high risk of recurrence after nephrectomy, or whose metastases have been removed surgically. In the LITESPARK-022 trial, 1841 patients were randomised to belzutifan or placebo in addition to pembrolizumab. At the interim analysis, the hazard ratio for disease-free survival was 0.72 (186 events in the belzutifan arm and 246 in the placebo arm); median values were not reached in either arm. Overall survival data are not yet mature. Pembrolizumab is given for up to 12 months and belzutifan for up to 54 weeks. The warning on fetal harm in pregnancy and adverse effects such as anaemia and hypoxia should be monitored.

    Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no product with belzutifan.

    • SGK Reimbursement
    • Kidney Cancer

    SGK removed the age limit of 65 for the combination of nivolumab and ipilimumab in advanced kidney cancer

    With the SUT amendment published in the Official Gazette of 17 January 2026 (no. 33140), the phrase “aged 65 or under” was removed from the reimbursement conditions of the nivolumab and ipilimumab combination in advanced-stage renal cell carcinoma. As a result, there is no longer an upper age limit for first-line use of this combination in previously untreated patients who are at intermediate or poor risk by the IMDC risk classification and have an adequate general condition (Karnofsky performance score of 70 or above). Ipilimumab is given for a maximum of four doses. The regulation entered into force 5 working days after publication. In older patients, the decision on immunotherapy is made by considering comorbidities, general condition and the risk of side effects together.

    Status in Turkey: Products containing nivolumab and ipilimumab are on the SGK EK-4/A list; use is based on a health board report that includes a medical oncology specialist.

Bladder Cancer

Bladder Cancer developments page
    • FDA Approval
    • Bladder Cancer

    In BCG-unresponsive non-muscle invasive bladder cancer, the approval of nogapendekin alfa inbakicept was expanded to include patients with papillary-only tumors

    The FDA expanded the indication of nogapendekin alfa inbakicept, given into the bladder (intravesically) together with BCG. It was approved in April 2024 for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS); the new decision also covers patients with high-grade papillary-only tumors without CIS. The expansion is not based on a new trial but on extrapolation of earlier data: in the QUILT-3.032 trial, the complete response rate was 62% in 77 patients with CIS, and among complete responders the response lasted at least 12 months in 58% and at least 24 months in 40%. The FDA concluded that both tumor types carry a similar risk in these patients. Common side effects include painful urination, blood in the urine, frequent urination and urinary tract infection. The label warns that delaying cystectomy can lead to spread of the disease. Treatment decisions should be made jointly by the urologist and the medical oncologist.

    Status in Turkey: No product containing nogapendekin alfa inbakicept appears in the TİTCK list of licensed medicinal products dated 09.10.2026.

    • FDA Approval
    • Bladder Cancer

    Enfortumab vedotin and pembrolizumab approved in muscle-invasive bladder cancer, including in cisplatin-eligible patients

    The FDA expanded the use of pembrolizumab with enfortumab vedotin before surgery (neoadjuvant) and after cystectomy (adjuvant) to cover all patients with muscle-invasive bladder cancer who are candidates for cystectomy. This regimen had been approved in November 2025 for patients who cannot receive cisplatin. In the KEYNOTE-B15/EV-304 trial, 808 cisplatin-eligible patients were randomised to this combination or to preoperative gemcitabine-cisplatin chemotherapy. The hazard ratio for event-free survival was 0.53 and for overall survival 0.65; median event-free survival was 48.5 months in the chemotherapy arm and had not yet been reached in the combination arm. The safety profile was similar to earlier trials of this combination in urothelial cancer. The treatment decision should be made jointly by a urologist and a medical oncologist.

    Status in Turkey: Enfortumab vedotin is licensed in Turkey but is not on the SGK EK-4/A list; the licence and reimbursement status of this use in Turkey has not yet been clarified.

    • FDA Approval
    • Bladder Cancer

    Durvalumab receives FDA approval together with BCG in high-risk non-muscle-invasive bladder cancer

    The FDA approved durvalumab together with BCG induction and maintenance therapy in adults with high-risk non-muscle-invasive bladder cancer who have not previously received BCG. High risk is defined by features such as a T1 tumour, a high-grade tumour, carcinoma in situ, or multiple, recurrent and large tumours. The POTOMAC trial enrolled 1018 patients after transurethral resection, who were randomised into three arms. Compared with BCG alone, durvalumab plus BCG gave a hazard ratio of 0.68 for disease-free survival; median values were not reached in either arm. Durvalumab is given every four weeks for up to 13 cycles. Warnings include immune-mediated adverse reactions.

    Status in Turkey: Durvalumab is licensed in Turkey for other indications; the licence and reimbursement status of this bladder cancer use in Turkey has not yet been clarified.

    • FDA Approval
    • Bladder Cancer

    Atezolizumab receives FDA approval in bladder cancer for patients with tumour DNA detected in the blood after surgery

    The FDA approved atezolizumab as adjuvant treatment in adults with muscle-invasive bladder cancer in whom molecular residual disease was detected by circulating tumour DNA (ctDNA) in the blood after radical cystectomy; a blood test measuring ctDNA was also approved as a companion diagnostic. In the IMvigor011 trial, 250 patients with ctDNA positivity detected by serial blood tests within 12 months after surgery were randomised to atezolizumab or placebo. Median disease-free survival was 9.9 versus 4.8 months (hazard ratio 0.64) and median overall survival 32.8 versus 21.1 months (hazard ratio 0.59). Treatment is given every four weeks for up to one year. Warnings include immune-mediated adverse reactions.

    Status in Turkey: Atezolizumab is licensed in Turkey for other indications; the licence and reimbursement status of this ctDNA-based adjuvant use in Turkey has not yet been clarified.

Melanoma

Melanoma developments page
    • FDA Approval
    • Melanoma

    Vusolimogene oderparepvec and nivolumab combination receives FDA accelerated approval in advanced melanoma

    The FDA granted accelerated approval to the use of vusolimogene oderparepvec, a genetically modified oncolytic virus therapy, together with nivolumab. The approval covers adults with unresectable advanced cutaneous melanoma whose disease progressed during treatment based on a PD-1-blocking antibody. The virus is injected into the tumour; nivolumab is given intravenously. The assessment is based on the single-arm, open-label IGNYTE trial in stage IIIB–IV patients: of 140 patients, 91 with at least one non-injected lesion were evaluated for efficacy; the objective response rate was 24.2% (95% confidence interval 15.8–34.3) and the median duration of response 14.1 months (10.7–not reached). Accelerated approval is based on response rate and duration of response; conducting a randomised phase 3 trial (IGNYTE-3) to confirm clinical benefit was made a requirement. Warnings on the label include accidental exposure, herpetic infection or reactivation, injection-procedure complications and immune-related events. The FDA held an advisory committee meeting on 30 July 2026 before the approval.

    Status in Turkey: The TİTCK list of licensed products dated 09.10.2026 contains no product with vusolimogene oderparepvec; nivolumab appears to be licensed as a separate product. The current TİTCK list is being followed for the licence and reimbursement status of this combination in Turkey.

Biliary Tract Cancer

Biliary Tract Cancers developments page
    • Promising Studies
    • Congress · ESMO 2026
    • Biliary Tract Cancer

    Gemcitabine + cisplatin compared with capecitabine after surgery for biliary tract cancer: results favourable but the primary analysis was borderline (ACTICCA-1)

    In bile duct (cholangiocarcinoma) and gallbladder cancer, recurrence can occur within two years in about half of patients even after surgery; the treatment widely used after surgery today is oral capecitabine. In the phase 3 ACTICCA-1 trial, conducted in Europe and Australia and funded independently of the pharmaceutical industry, 591 patients received gemcitabine + cisplatin or capecitabine for 24 weeks after surgery. At about 5 years of follow-up, median time without recurrence was 2.14 years with gemcitabine + cisplatin and 1.49 years with capecitabine; however, the trial’s main statistical test did not reach the significance threshold. A prespecified additional analysis showed an average of about 2.6 months longer disease-free time over the first 3 years with gemcitabine + cisplatin. There was a favourable trend in survival, but the difference was not significant. Serious side effects were slightly more frequent with gemcitabine + cisplatin. These results suggest there may be one more option when choosing treatment after surgery, but they do not show clear superiority. The decision on post-surgery treatment in biliary tract cancer requires joint assessment by medical oncology, hepatobiliary surgery, gastroenterology, radiology and pathology.

    These results are clinical trial data presented at a congress; they do not imply an approved use. Treatment decisions are made at a multidisciplinary tumour board, considering tumour type, stage, general health and previous treatments together.

    Status in Turkey: Products containing gemcitabine, cisplatin and capecitabine are on the TİTCK list of licensed products dated 16.10.2026 and on the SGK EK-4/A list dated 23.10.2026. The reimbursement scope of gemcitabine + cisplatin after surgery for biliary tract cancer could not be verified.

    • FDA Approval
    • Biliary Tract Cancer

    Lirafugratinib received FDA approval for cholangiocarcinoma with an FGFR2 fusion

    The FDA approved lirafugratinib, a kinase inhibitor, for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (biliary tract cancer) with an FGFR2 gene fusion or other rearrangement. The assessment is based on the single-arm, open-label REFOCUS trial in 116 patients who had not previously received an FGFR inhibitor and had received chemotherapy or chemo-immunotherapy. The objective response rate assessed by an independent committee according to RECIST v1.1 was 46% (95% confidence interval 36–55) and the median duration of response 11.8 months (95% confidence interval 7.5–13.0). The label includes warnings for ocular toxicity, hyperphosphataemia and soft tissue mineralisation, and for embryo-fetal toxicity. The FDA reviewed the application under priority review.

    Status in Turkey: The TİTCK list of licensed products dated 09.10.2026 contains no product with lirafugratinib.

    • FDA Approval
    • Biliary Tract Cancer

    Zenocutuzumab receives FDA approval in cholangiocarcinoma with an NRG1 fusion

    The FDA approved zenocutuzumab for adults with advanced, unresectable or metastatic cholangiocarcinoma carrying an NRG1 (neuregulin 1) gene fusion whose disease progressed during or after systemic therapy. The FDA describes NRG1-fusion cholangiocarcinoma as an extremely rare and life-threatening disease. The assessment is based on the cholangiocarcinoma cohort of the multi-cohort, open-label eNRGy trial in adults with advanced solid tumours: 22 patients were enrolled and 19 were evaluated for efficacy; the confirmed objective response rate was 36.8% (95% confidence interval 16.3–61.6) and the duration of response ranged from 2.8 to 12.9 months. Because the number of patients is very small, these results should be interpreted with caution. The label includes warnings for infusion-related reactions, hypersensitivity and anaphylaxis, interstitial lung disease or pneumonitis, left ventricular dysfunction and embryo-fetal toxicity.

    Status in Turkey: The TİTCK list of licensed products dated 09.10.2026 contains no product with zenocutuzumab.

Sarcomas

Sarcomas developments page
    • Promising Studies
    • Congress · ESMO 2026
    • Sarcomas

    In relapsed osteosarcoma, the antibody–drug conjugate risvutatug rezetecan prolonged disease control compared with chemotherapy (ARTEMIS-011)

    Osteosarcoma is a bone cancer seen mostly in adolescents and young adults; when it recurs after several lines of treatment, options have been very limited for many years. In the phase 3 ARTEMIS-011 trial conducted in China, 122 patients aged 12 years and older whose disease had progressed after at least two previous treatments were randomly assigned to risvutatug rezetecan, which binds to the B7-H3 protein on the tumour surface and carries the drug directly into the tumour cell, or to gemcitabine plus docetaxel chemotherapy. Median time until the disease progressed was 5.5 versus 1.4 months (HR 0.33). Overall survival data are not yet mature. Serious side effects, especially low blood counts, were more frequent in the drug group; no treatment-related deaths were reported. The study is small, follow-up is short and the drug is not yet approved anywhere. In osteosarcoma, treatment is planned through joint assessment by orthopaedic oncology, medical oncology, paediatric oncology where needed, radiology and pathology.

    These results are clinical trial data presented at a congress; they do not imply an approved use. Treatment decisions are made at a multidisciplinary tumour board, considering tumour type, stage, general health and previous treatments together.

    Status in Turkey: No product containing risvutatug rezetecan is on the TİTCK licensed medicinal products list dated 16.10.2026. There is no licence or SGK reimbursement in Turkey; treatment options should be discussed with your doctor.

How is this page prepared?

  • FDA approvals are taken from the oncology approval notifications of the US Food and Drug Administration. An FDA approval does not mean that the drug can be used in Turkey.
  • Turkey licences are verified against the TİTCK list of licensed products and the approved Summary of Product Characteristics (KÜB) documents. The licence date is not necessarily the date on which the drug is available in a pharmacy or hospital.
  • SGK reimbursement news is based on SUT amendments published in the Official Gazette and on the SGK list of reimbursed medicines (EK-4/A). Reimbursement is limited to the conditions written in the SUT.
  • Promising studies are results published in peer-reviewed journals; they are not yet an approved treatment and do not amount to a drug approval.

Drugs are referred to by their active ingredient names. Numerical results are reported as stated in the source; if the hazard ratio (HR) is below 1, the result favours the new treatment.

The news on this page is for general information only; it is not a diagnosis or treatment recommendation. Whether a treatment is suitable for you is decided together with your physician after assessing the characteristics of your disease.

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Assessing what a development means for your situation requires considering your diagnosis, stage, molecular test results and previous treatments together. You can write or call to make an appointment or request a second opinion.

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The news on this page is for general information only; it is not a diagnosis or treatment recommendation. Whether a treatment is suitable for you is decided together with your physician after assessing the characteristics of your disease.