Latest Developments
New approvals, Turkey licence and SGK reimbursement news by cancer type, notable studies.
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Breast Cancer: Latest Developments
Sources reviewed by: Assoc. Prof. Dr. Ali OğulLast updated:
Short summaries of recently published approvals, licensing and reimbursement regulations in Turkey, and notable studies in breast cancer. For general information about the disease, see the Breast Cancer page.
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Showing 7 developments
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.
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.
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 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.
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.
- Source:
- FDA announcement (18 September 2026)
- EMBER-3 trial, ClinicalTrials.gov NCT04975308
- EMBER-3 primary publication, N Engl J Med
- TİTCK List of Licensed Human Medicinal Products
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.
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.
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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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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.