Panel found fault with how the late-stage trial was conducted
Amgen Inc. said it would continue to work closely with the Food and Drug Administration to seek full approval for its Lumakras cancer drug as a treatment for a form of lung cancer, after an advisory panel found fault with a late-stage trial on Thursday.
The panel was asked to vote on whether the primary endpoint, progression-free survival per blinded independent central review , could be reliably interpreted and voted 10 to 2 that it could not.“We will continue to progress our comprehensive global KRASG12C inhibitor development program exploring multiple LUMAKRAS combination regimens, including in colorectal cancer,” Amgen said in a statement.
Experts found that the trial allowed too many patients to switch between the control and treatment arms and that too many withdrew consent for the data to be relied on. Mizuho analysts said the fact that the purpose of the meeting was not to remove Kumakras from the market was a positive for future oncology trials.
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US FDA panel gives thumbs down on approval for Amgen lung cancer drugAdvisers to the U.S. Food and Drug Administration on Thursday found that data from a late-stage trial was not reliable enough to support traditional approval of Amgen's (AMGN.O) Lumakras for patients with a type of advanced lung cancer.
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Amgen to continue to seek full approval of Lumakras cancer drug after FDA panel votes against itPanel found fault with how the late-stage trial was conducted
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