STAT+: FDA advisory panel signals lack of confidence in data on Amgen’s cancer drug
The clearance of a first-of-its-kind cancer treatment made by Amgen is on shakier ground following a Food and Drug Administration advisory committee.
The clearance of a first-of-its-kind cancer treatment made by Amgen is on shakier ground following a Food and Drug Administration advisory committee meeting Thursday.
Regulatory advisers voted 10-2 that the data on the company’s drug Lumakras, a treatment for lung cancer, could not be properly assessed. Lumakras targets a specific mutation to a protein called KRAS, which is one of the most common genetic mutations in cancer.
The vote comes as Amgen is hoping to convert a conditional approval for the drug to a full approval based on a 345-person study called CodeBreaK 200, in which Lumakras met the primary endpoint, delaying tumor growth approximately five weeks longer than the standard of care medication, docetaxel. The drug didn’t extend patients’ overall survival.
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