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A follow-up study of a first-of-its-kind cancer treatment may reflect systemic biases, the Food and Drug Administration said ahead of an advisory committee meeting Thursday to determine whether the drug should remain on the market.

The treatment, Lumakras, is designed to treat lung cancer caused by a specific genetic mutation to a protein called KRAS. It’s one of the most common genetic mutations in cancer, but repeated clinical trial failures had led researchers to deem it “undruggable” until a glimmer of hope came about a decade ago.


Lumakras received an accelerated, or conditional, approval in May 2021, making it the first KRAS drug on the market. Now, the drug’s manufacturer, Amgen, needs to prove it works.

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