Amgen’s NDA for Lumakras cancer treatment resulted in complete response letter

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….