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.

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