Incyte Corporation announced that the Committee for Medicinal Products for Human Use $(CHMP)$ of the European Medicines Agency $(EMA)$ has issued a positive opinion recommending the approval of Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). The recommendation is based on results from the Phase 3 POD1UM-303/InterAACT2 trial, which demonstrated a statistically significant improvement in progression-free survival for patients receiving the combination therapy. The CHMP opinion is now under review by the European Commission, which will make the final decision on marketing authorization in the European Union.

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