Incyte Corp.’s (INCY) Retifanlimab, proposed for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal, is under FDA priority review, with a decision date set for July 25.Retifanlimab (formerly INCMGA0012), an intravenous anti-PD1 antibody, was licensed to Incyte by MacroGenics Inc in 2017, under an exclusive global collaboration and license agreement. In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of Retifanlimab in Greater China.On June 24, an FDA panel voted 13-4 that a regulatory decision on Retifanlimab should be deferred until further data are available from a confirmatory trial that is underway.The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.Squamous cell carcinoma of the anal canal (SCAC) is associated with human papillomavirus (HPV) and HIV infections and accounts for almost 3% of digestive system cancers. Patients with metastatic SCAC have a poor 5-year survival, and there are no FDA-approved treatments for patients who have progressed after first-line chemotherapy.Analysts at SVB Leerink projects peak sales of about $100 million for Retifanlimab in 2030.