NasdaqGS:INCYBiotechs
Incyte’s Zynyz Wins CHMP Backing And Opens New EU Opportunity
The CHMP of the EMA issued a positive opinion on Incyte's Zynyz (retifanlimab) in combination with platinum-based chemotherapy.
The recommendation covers first-line treatment of adults with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal.
The decision is based on Phase 3 data showing improved progression-free survival with no new safety signals.
This opinion represents a key step toward potential European approval and market entry for Zynyz.
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