Incyte Receives FDA CRL for Zynyz NSCLC Expansion Due to Issues at Novo Nordisk's Catalent Indiana Facility, Becoming Third Affected Company

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On February 27, 2026, the FDA issued a Complete Response Letter (CRL) to Incyte's supplemental Biologics License Application (sBLA) for Zynyz (retifanlimab-dlwr) in combination with platinum-based chemotherapy for metastatic non-small cell lung cancer (NSCLC).123

The CRL cited inspection findings and regulatory compliance issues at Catalent Indiana, LLC—a third-party fill-finish facility owned by Novo Nordisk—as the sole approvability barrier, with no concerns raised about Zynyz's efficacy, safety data from the Phase 3 POD1UM-304 trial, or the drug substance manufacturer.1234

Incyte is collaborating with the FDA and Catalent Indiana to address the issues and prepare a potential resubmission, though no timeline was specified.123

This marks the third CRL linked to Catalent Indiana:
previous rejections in September/October 2025 affected Scholar Rock's apitegromab for spinal muscular atrophy and Regeneron's high-dose Eylea pre-filled syringe.2

The facility has faced prior FDA scrutiny since Novo acquired Catalent in February 2024, including issues like cat hair contamination, pest infestations, and equipment failures revealed in August 2025, leading to an Official Action Indicated classification in October 2025.2

Sources:

1. https://www.gurufocus.com/news/8686518/incyte-corporation-incy-receives-fda-complete-response-letter-for-zynyz-sbla

2. https://www.biospace.com/fda/incytes-lung-cancer-expansion-bid-thwarted-by-issues-at-novos-catalent-acquired-site

3. https://www.sec.gov/Archives/edgar/data/879169/000087916926000013/incy-20260227.htm

4. https://www.stocktitan.net/sec-filings/INCY/8-k-incyte-corp-reports-material-event-104beb95f2b7.html