Incyte said on February 27, 2026 the U.S. Food and Drug Administration issued a Complete Response Letter for the supplemental Biologics License Application for Zynyz (retifanlimab-dlwr) injection (375mg) for an additional indication.

1. 01

   Incyte said on February 27, 2026 the U.S. Food and Drug Administration issued a Complete Response Letter for the supplemental Biologics License Application for Zynyz (retifanlimab-dlwr) injection (375mg) for an additional indication.

2. 02

   The company said the sBLA was for an additional indication for the treatment of adult patients with metastatic non-small cell lung cancer in combination with platinum-based chemotherapy.

3. 03

   Incyte said the CRL cited inspection findings (not specific to Zynyz) at Catalent Indiana, LLC, the 3-party fill-finish facility referenced in the sBLA and part of Novo Nordisk, and presented the regulatory compliance of that facility as the sole approvability issue.

4. 04

   The company said the CRL did not cite Zynyz's efficacy and safety data in NSCLC or the 3-party drug substance manufacturer. Incyte added it is working closely with the FDA and Catalent Indiana to address the CRL and support a potential sBLA resubmission of Zynyz in NSCLC.

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