Posted by Michael Wonder on 07 Feb 2026
Incyte announces positive CHMP opinion for Zynyz (retifanlimab) for first-line treatment of advanced squamous cell carcinoma of the anal canal
30 January 2026 - The CHMP positive opinion is based on data from the Phase 3 POD1UM-303/InterAACT2 trial which showed patients with advanced SCAC achieved significantly improved progression-free survival with Zynyz in combination with carboplatin and paclitaxel as a first-line treatment.
Incyte today announced that the CHMP of the EMA has issued a positive opinion recommending the approval of 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.
