Incyte Corporation (INCY) Receives FDA Complete Response Letter for Zynyz® sBLA

2026-03-29 23:48:22

Incyte Corporation (INCY) received a Complete Response Letter (CRL) from the FDA for its Zynyz® sBLA for metastatic non-small cell lung cancer, citing regulatory compliance issues at a third-party manufacturing facility. The FDA’s decision was not based on concerns about the drug’s efficacy or safety. Incyte is working with the FDA and the facility to address the issues for a potential resubmission.

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