INCY - Incyte's retifanlimab application validated in Europe for anal cancer

The EMA has validated Incyte's (INCY) Marketing Authorization Application ((MAA)) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma ((SCAC)) who are intolerant of, platinum-based chemotherapy.The validation confirms that the submission is sufficiently complete to begin the formal review process. The MAA is based on the data from Phase 2 POD1UM-202 trial evaluating retifanlimab in patients with SCAC intolerant to standard platinum-based chemotherapy. The FDA has granted Orphan Drug Designation to retifanlimab for the treatment of anal cancer, and the BLA has been accepted for Priority Review. In 2017, Incyte inked licensing deal with MacroGenics for global rights to retifanlimab. In 2019, Incyte and Zai Lab collaborated for the development and commercialization of retifanlimab in Greater China.

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Incyte's retifanlimab application validated in Europe for anal cancer