FDA issues Complete Response Letter for Incyte's Zynyz in NSCLC due to facility inspection findings

INCYTE CORP

FDA CRL for Zynyz (retifanlimab) sBLA for metastatic NSCLC with platinum chemo, citing Catalent Indiana inspection findings.
CRL did not cite efficacy or safety concerns; Zynyz's data from Phase 3 POD1UM-304 trial remains positive.
Incyte working with FDA and Catalent Indiana to address CRL and support potential sBLA resubmission.
The inspection findings at Catalent Indiana (part of Novo Nordisk) are not specific to Zynyz.
No other approvability issues raised; drug substance manufacturer not a concern.

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