Incyte Corporation has announced the FDA approval of Zynyz® (retifanlimab-dlwr), marking it as the first and only approved first-line treatment for patients with advanced squamous cell carcinoma of the anal canal (SCAC) in the United States. Zynyz, a PD-1 inhibitor, is approved for use both in combination with chemotherapy and as a monotherapy, offering significant improvements in progression-free and overall survival for patients. Incyte has also submitted a Type II variation Marketing Authorization Application to the European Medicines Agency and a Japanese New Drug Application, which has been accepted by the Pharmaceuticals and Medical Devices Agency. This approval represents a significant advancement in treatment options for a condition with previously limited options.