FDA Approves Zynyz as First-Line Treatment for Advanced Anal Cancer

WEDNESDAY, May 21, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved the humanized monoclonal antibody, Zynyz, (retifanlimab-dlwr) as the first first-line treatment for advanced anal cancer.

Zynyz is a programmed death receptor-1 inhibitor, approved in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for adults with inoperable, locally recurrent, or metastatic squamous cell carcinoma of the anal canal (SCAC). Additionally, the FDA granted approval for Zynyz as a single agent for patients with locally recurrent or with metastatic SCAC with disease progression on or intolerant to platinum-based chemotherapy.

The approval is based on results from the phase 3 POD1UM-303/InterAACT2 trial, which showed a clinically meaningful 37 percent reduction in the risk of progression or death in patients with SCAC. Compared to placebo, patients in the Zynyz and chemotherapy combination group achieved a longer median progression-free survival (9.3 versus 7.4 months), as well as a 6.2-month improvement in median overall survival at an interim analysis. No new safety signals were reported.

Serious adverse reactions occurred in 47 percent of patients receiving Zynyz in combination with chemotherapy, including sepsis (3.2 percent), pulmonary embolism (3.2 percent), diarrhea (2.6 percent), and vomiting (2.6 percent).

“Patients with anal cancer often face a troubling lack of public awareness and understanding when it comes to risk factors, symptoms, and their overall cancer journey,” David Winterflood, chief executive officer of the Anal Cancer Foundation. “The approval of Zynyz marks a step forward for advanced SCAC treatment, brings attention to a long-overlooked condition with limited treatment options and offers patients whose anal cancer has returned or spread an option to treat their disease.”

Approval of Zynyz was granted to Incyte.

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