WILMINGTON, DE — The European Commission has approved Zynyz (retifanlimab), developed by Incyte (Nasdaq: INCY), in combination with carboplatin and paclitaxel for the first-line treatment of adults with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal, the company announced.
The approval allows the drug to be used as a systemic treatment for patients with advanced disease in Europe.
The decision follows a positive opinion issued in January 2026 by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
The approval was based on results from the Phase 3 POD1UM-303 clinical trial, which evaluated retifanlimab or placebo in combination with platinum-based chemotherapy in patients with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal who had not previously received systemic chemotherapy.
Trial results showed a 37 percent reduction in the risk of disease progression or death for patients receiving retifanlimab with chemotherapy compared with chemotherapy alone.
Patients receiving the combination therapy had a median progression-free survival of 9.3 months, compared with 7.4 months for those receiving chemotherapy with placebo.
The results were published in The Lancet.
Serious adverse reactions occurred in 47 percent of patients receiving retifanlimab with chemotherapy, with the most frequent including sepsis, pulmonary embolism, diarrhea and vomiting.
Bill Meury, president and chief executive officer of Incyte, said the approval expands treatment options for a rare cancer that has seen limited therapeutic advances.
“The EC approval of Zynyz marks an important step forward for patients with advanced SCAC, a rare cancer for which meaningful treatment advances have not occurred in several decades,” Meury said.
Squamous cell carcinoma of the anal canal accounts for about 85 percent of anal cancer cases worldwide and is estimated to affect one to two people per 100,000 annually.
About 90 percent of cases are associated with human papillomavirus infection, according to the company.
Zynyz is a monoclonal antibody that targets the programmed death receptor-1 (PD-1) immune checkpoint.
The drug had previously been approved in Europe as a monotherapy for the first-line treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.
Incyte markets Zynyz in the United States and holds global rights to retifanlimab through a collaboration and license agreement with MacroGenics Inc.
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