Drugs

CRL for Amgen Lumakras sNDA

FDA has issued a complete response letter for the Amgen sNDA that sought full approval for its Lumakras (sotorasib). The company says the agency’s review was based on the CodeBreak 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer.

In the letter, FDA issued a new postmarketing requirement for an additional confirmatory study to support full approval that Amgen says will be completed no later than 2/2028. The agency also concluded that the dose comparison postmarketing requirement issued at the time Lumakras received accelerated approval to compare the safety and efficacy of Lumakras 960 mg daily dose versus a lower daily dose has been fulfilled, with the 960 mg dose confirmed.

Lumakras received accelerated approval in 5/2021 as the first KRASG12C inhibitor to receive regulatory approval in the U.S.

CRL for Amgen Lumakras sNDA

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