FDA Approval Alert: The Need-to-Know | Retifanlimab/Chemotherapy in Recurrent/Metastatic Anal Cancer

In May 2025, the FDA approved retifanlimab-dlwr plus platinum-based chemotherapy with carboplatin and paclitaxel as frontline treatment for adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The agency also approved retifanlimab as monotherapy for adults with recurrent or metastatic SCAC who experienced progressive disease or intolerance associated with platinum-containing chemotherapy.