Regulatory update on status of Lumakras (sotorasib)
Amgen announced that the FDA has completed its review of the company's supplemental New Drug Application seeking full approval of Lumakras (sotorasib)
This review, which resulted in a Complete Response Letter, 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 (NSCLC). The FDA also issued a new postmarketing requirement (PMR) for an additional confirmatory study to support full approval that will be completed no later than February 2028.
In addition, the FDA concluded that the dose comparison PMR issued at the time of Lumakras accelerated approval, to compare the safety and efficacy of Lumakras 960 mg daily dose versus a lower daily dose, has been fulfilled. The company said Lumakras at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated NSCLC under accelerated approval. In May 2021, Lumakras was the first KRASG12C inhibitor to receive regulatory approval in the U.S., under accelerated approval. To date, over 15,000 patients worldwide have received Lumakras/Lumykras through the clinical development program, early access and commercial use.
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