US FDA approved Zynyz for Merkel cell carcinoma

CAR-T Digest - August 2020

March 22, 2023: Zynyz (Retifanlimab, IV)/ Merkel Cell Carcinoma/ Incyte Corporation: Zynyz Received US FDA approval

Incyte announced US FDA approval for Zynyz for the treatment of adults with metastatic or recurring locally advanced Merkel cell carcinoma
- Approved under accelerated approval based on tumor response rate and duration of response
- Continuation of approval may be contingent on confirmatory trials
The approval was based on the positive data from the POD1UM-201 trial
- Phase 2 trial in advanced MCC who had not received prior systemic therapy will be administered Retifanlimab (500mg Q4W, IV)
- Efficacy: ORR (52%); DOR (1.1 to 24.9+ months)
- Safety: Serious adverse events (22%)
“….Incyte is grateful to the investigators and patients around the world who participated in the POD1UM-201 trial. We continue to study the potential of Zynyz in additional tumor types and combination with other Incyte pipeline compounds.” said Hervé Hoppenot, CEO of Incyte