Latest Developments
New approvals, Turkey licence and SGK reimbursement news by cancer type, notable studies.
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Lung 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 lung cancer. For general information about the disease, see the Lung Cancer page.
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Showing 6 developments
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.
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.
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.
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.
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 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.
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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.