Amgen Inc. AMGN said Tuesday that the regulatory review of its supplemental new drug application seeking full approval of Lumakras resulted in a “complete response letter” from the U.S. Food and Drug Administration. A CRL means the application will not be approved in its current form. The biotechnology company said the FDA also issued a new postmarketing requirement of an additional study to support full approval, to be completed no later than February 2028. The NDA for Lumakras was based on results of a trial for the treatment of adults with previously treated locally advanced or matastatic non-small cell lunch cancer….
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