STAT+: Lawmaker accuses Amgen of placing profits above patients with dosing for a cancer drug
A U.S. lawmaker is accusing Amgen of “putting profits before patients” over its decision to continue marketing a high dose of a pricey cancer treatment instead of a lower dose that is less expensive and not as toxic to patients.
At issue is a medication called Lumakras, which is used to treat non-small cell lung cancer and which won conditional regulatory approval three years ago. At the time, the U.S. Food and Drug Administration required Amgen to run a trial confirming earlier test results, as well as a so-called post-marketing study to examine safety and effectiveness at different dosages, in order to gain full approval.
Last December, the agency determined the confirmatory trial was not acceptable and asked the company to run yet another trial, which must be completed by February 2028. Meanwhile, the company was allowed to continue offering a 960-mg dose of the drug, which the FDA originally did not believe was optimal, since a study released last October found its efficacy was similar to that of a 240-mg dosage.
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