FDA issues Complete Response Letter for Incyte’s Zynyz NSCLC sBLA over Catalent Indiana compliance findings

Reuters03-07

FDA issues Complete Response Letter for Incyte’s Zynyz NSCLC sBLA over <a href="https://laohu8.com/S/CTLT">Catalent</a> Indiana compliance findings

Incyte said the FDA issued a Complete Response Letter for its supplemental biologics license application seeking approval of Zynyz for metastatic non-small cell lung cancer in combination with platinum chemotherapy. The company said the only approvability issue cited was regulatory compliance inspection findings at Catalent Indiana, a third-party fill-finish facility referenced in the application, and not Zynyz’s efficacy or safety data. Incyte said it is working with the FDA and Catalent to address the findings and support a potential resubmission.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Incyte Corporation published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0000879169-26-000013), on March 06, 2026, and is solely responsible for the information contained therein.

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