The European Medicines Agency (EMA) has recommended expanding the therapeutic use of Zynyz (retifanlimab) to treat adults with metastatic or locally recurrent squamous cell carcinoma of the anal canal (SCAC) that cannot be surgically removed. The recommendation is based on a clinical trial involving 308 patients, where those receiving Zynyz combined with chemotherapy lived 9.3 months without cancer progression compared to 7.4 months with placebo. While longer survival rates were not statistically significant, EMA concluded the treatment shows potential benefit. Common side effects include neutropenia, rash, and hypothyroidism. The opinion will now be reviewed by the European Commission for potential EU-wide approval. National health systems will later decide on pricing and reimbursement. SCAC, a rare but aggressive cancer, affects around 10,000 people annually in the EU, with poor outcomes for advanced stages.
© European Medicines Agency (1995‑).
Summary adapted from EMA materials available at https://www.ema.europa.eu
https://www.ema.europa.eu/en/news/first-immunotherapy-based-treatment-recommended-advanced-anal-cancer
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