FDA denies full approval of Amgen lung cancer drug

Dec. 27, 2023

The U.S. FDA has completed its review of Amgen's sNDA seeking full approval of the company's KRASG12C inhibitor for lung cancer, issuing a complete response letter and requesting an additional confirmatory trial.

In May 2021, the therapy, branded Lumakras, became the first KRASG12C inhibitor to receive regulatory approval in the U.S., under accelerated approval. In pursuit of full approval, Amgen launched the confirmatory CodeBreaK 200 trial, a phase 3 study which enrolled patients with locally advanced/unresectable or metastatic KRAS G12C–mutated non-small cell lung cancer (NSCLC) who received 1 or more previous treatments.

But there were hints that the trial was not going to cut it for traditional approval. When the FDA’s Oncologic Drug Advisory Committee met back in October, they voted 10-2 that the progression-free survival of Lumakras could not be reliably interpreted versus current standard of care, docetaxel, in the CodeBreaK 200 study.

Now, the FDA has issued a new postmarketing requirement for an additional confirmatory study to support full approval that has to be completed no later than February 2028.

According to Amgen, KRAS G12C is the most common KRAS mutation in NSCLC. Unmet medical need remains high and treatment options are limited for NSCLC patients with the mutation whose first-line treatment has failed to work or has stopped working.