The U.S. FDA has rejected an additional indication for Zynyz, a cancer treatment from Incyte INCY and MacroGenics (MGNX), following concerns at a third-party manufacturing site operated by Novo Nordisk’s Catalent unit. Incyte (INCY) reported receiving a Complete Response Letter regarding its supplemental Biologics License Application, which aimed to expand Zynyz's use in combination with chemotherapy for metastatic non-small cell lung cancer. The FDA's decision was solely based on compliance issues at Catalent Indiana, with no other concerns noted. Incyte plans to work with the FDA and Catalent to resolve these issues and resubmit the application.
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