Following two simultaneous FDA approvals, Incyte’s PD-1 inhibitor Zynyz has made a comeback in the treatment of anal cancer, four years after being initially rejected by the agency. On May 15, 2025, Incyte announced that the FDA approved Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody that targets the PD-1, for use in combination with carboplatin and paclitaxel as a first-line treatment for adults with inoperable, locally recurrent, or metastatic squamous cell carcinoma of the anal canal (SCAC).
Additionally, Zynyz received approval as a standalone therapy for adults with locally recurrent or metastatic SCAC who have experienced disease progression on or...
