Full Approval For Amgen's Flagship Cancer Drug Lumakras Pushed For Around Four Years

Amgen Inc AMGN announced that the FDA has reviewed the company's supplemental New Drug Application, seeking full approval of the KRAS-blocking drug Lumakras (sotorasib). 

In October, the FDA advisers voted 10-2, expressing doubts about relying on the primary goal of the late-stage confirmatory study to assess the Lumakras's benefits.

This review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). 

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The FDA also issued a new post-marketing 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. 

Over 15,000 patients worldwide have received Lumakras/Lumykras through the clinical development program, early access, and commercial use.

In August, Amgen said Lumakras succeeded in the Phase 3 CodeBreaK 300 trial, delaying the progression of chemorefractory metastatic KRAS G12C mutated colorectal cancer.

Price Action: AMGN shares are down 0.45% at $282.89 on the last check Tuesday.