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Incyte Announces the European Commission Approval of Zynyz® (retifanlimab) for the First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC)
- Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) is the first systemic treatment for adult patients with
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[{"type":"text","content":"\n- Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) is the first systemic treatment for adult patients with advanced SCAC in Europe\n\n\n- The EC approval is based on results of the POD1UM-303 study which showed that adult patients with advanced SCAC achieved significantly improved progression-free survival with Zynyz in combination with carboplatin and paclitaxel as a first-line treatment compared to chemotherapy alone.1\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).\n\n\n“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,” said Bill Meury, President and Chief Executive Officer, Incyte. “As the first PD-1 immunotherapy approved in Europe in combination with platinum-based chemotherapy in the first-line setting, Zynyz helps expand the standard-of-care options available to clinicians and underscores our commitment to delivering innovative medicines that can have an impact for patients.”\n\n\nThe EC decision follows the January 2026 positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This marks the second indication in Europe for Zynyz, which was previously approved by the EC as a monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.\n\n\nThis approval is based on data from the Phase 3 POD1UM-303/InterAACT2 trial (NCT04472429) evaluating Zynyz or placebo in combination with platinum-based chemotherapy (carboplatin and paclitaxel) in adult patients with metastatic or inoperable locally recurrent SCAC not previously treated with systemic chemotherapy.1\n\n\nResults from the trial, also published in The Lancet, demonstrated a statistically significant 37% reduction in the risk of progression or death (P=0.0006).1 Patients in the Zynyz and chemotherapy combination group achieved a median progress...