INCY · Incyte Corporation

Summary

Incyte Corporation disclosed that on February 27, 2026, the FDA issued a Complete Response Letter for the sBLA of Zynyz® (retifanlimab-dlwr) for metastatic NSCLC in combination with platinum-based chemotherapy, citing inspection findings at third-party fill-finish facility Catalent Indiana as the sole approvability issue. Incyte is working with the FDA and Catalent Indiana to address the CRL for potential resubmission.

Key takeaways

• FDA issued CRL on February 27, 2026 for Zynyz sBLA
• sBLA seeks indication for adult patients with metastatic NSCLC in combination with platinum-based chemotherapy
• CRL supported by Phase 3 POD1UM-304 trial data announced December 2024
• Sole issue: inspection findings at Catalent Indiana, part of Novo Nordisk
• No concerns raised on Zynyz efficacy, safety data or drug substance manufacturer
• Incyte working with FDA and Catalent Indiana for potential sBLA resubmission