Latest Developments
New approvals, Turkey licence and SGK reimbursement news by cancer type, notable studies.
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Melanoma: 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 melanoma. For general information about the disease, see the Melanoma page.
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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.
- Source:
- FDA announcement (6 August 2026)
- FDA approval letter (6 August 2026): post-approval confirmatory trial IGNYTE-3
- IGNYTE trial, ClinicalTrials.gov NCT03767348
- TİTCK List of Licensed Human Medicinal Products
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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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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.
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.