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

Amgen Inc. AMGN, -0.67% 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 result ...