Retifanlimab
Retifanlimab, sold under the brand name Zynyz, is an anti-cancer medication used for the treatment of Merkel cell carcinoma.[2] Retifanlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.[2] It was approved for medical use in the United States in March 2023,[4][5][6] and in the European Union in April 2024.[3] Medical usesRetifanlimab is indicated for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.[2][4][7][3] In May 2025, the US Food and Drug Administration (FDA) expanded the indication for retifanlimab to include, when used with carboplatin and paclitaxel, the first-line treatment of adults with inoperable locally recurrent or metastatic squamous-cell carcinoma of the anal canal.[8] The FDA also approved retifanlimab, as a single agent, for adults with locally recurrent or metastatic squamous-cell carcinoma of the anal canal with disease progression on or intolerance to platinum-based chemotherapy.[8] Adverse effectsThe US Food and Drug Administration (FDA) prescription label for retifanlimab includes warnings and precautions for severe and fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.[8] HistoryThe US Food and Drug Administration (FDA) evaluated the safety and efficacy of retifanlimab based on PODIUM-201 (NCT03599713), an open-label, multiregional, single-arm study evaluating 65 participants with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy for advanced disease.[4] The FDA granted the application for retifanlimab priority review, fast track, and orphan drug designations.[4] The efficacy of retifanlimab with carboplatin and paclitaxel was evaluated in POD1UM-303/InterAACT 2 (NCT04472429), a randomized, multi-center, double-blind trial in 308 participants with chemotherapy-naïve inoperable locally recurrent or metastatic squamous-cell carcinoma of the anal canal.[8] Participants received carboplatin AUC of 5 on day 1, and paclitaxel 80 mg/m2 on days 1, 8, and 15 for 6 cycles and were randomized (1:1) to receive either retifanlimab 500 mg intravenously every 4 weeks; or placebo intravenously every 4 weeks.[8] The efficacy of retifanlimab as a single agent was evaluated in POD1UM-202 (NCT03597295), an open-label, multi-center, single-arm trial in 94 participants with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.[8] Participants received retifanlimab 500 mg intravenously every 4 weeks until disease progression, unacceptable toxicity, or up to 24 months.[8] Society and cultureLegal statusIn February 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zynyz, intended for the treatment of Merkel cell carcinoma.[3] The applicant for this medicinal product is Incyte Biosciences Distribution B.V.[3] Retifanlimab was authorized for medical use in the European Union in April 2024.[3] NamesRetifanlimab is the international nonproprietary name.[9] Retifanlimab is sold under the brand name Zynyz.[2][3] References
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