LUMAKRAS FDA approval : Amgen bags approval in KRAS G12C-mutated NSCLC


FDA approval : has bagged accelerated approval from the US Food and Drug Administration (FDA) for LUMAKRAS (sotorasib) for the treatment of a type of non-small cell cancer (NSCLC) in adults.

The approval is for the treatment of patients whose cancer is locally advanced or metastatic and have KRAS G12C mutation, as determined by an FDA-approved test and who have been subjected to at least one prior systemic therapy.

FDA approval is based on overall response rate (ORR) and duration of response (DoR). Its continued approval for the indication may be subject to the drug proving clinical benefit in a confirmatory trial(s), said Amgen.

Commenting on LUMAKRAS FDA approval, David M. Reese – executive vice president of Research and Development at Amgen, said: “The FDA approval of LUMAKRAS is a breakthrough moment for patients with KRAS G12C-mutated non-small cell cancer because there is now a targeted therapy for this common, but previously elusive, mutation.

“KRAS has challenged cancer researchers for more than 40 years with many deeming it as ‘undruggable.’ The LUMAKRAS development program was a race against cancer for Amgen’s scientists and clinical trial investigators who together have now successfully delivered this new medicine to patients in less than three years—from first patient dosed to U.S. regulatory approval.”

Amgen LUMAKRAS FDA approval - LUMAKRAS product shot

bags LUMAKRAS FDA approval in KRAS G12C-mutated NSCLC

How won LUMAKRAS FDA approval

LUMAKRAS FDA approval has been driven by the findings gathered from a subset of patients in the CodeBreaK 100 phase 1/2 clinical trial in patients with the KRAS G12C mutation.

The clinical trial showed favorable efficacy and tolerability in 124 patients whose disease had progressed after treatment with an immunotherapy and/or chemotherapy.

In the CodeBreaK 100 trial, 960 mg of LUMAKRAS orally administered daily once delivered an ORR of 36% with 81% of patients achieving disease control. The median DoR of treatment with the KRASG12C inhibitor was 10 months.

Bob T. Li – principal investigator of the CodeBreaK 100 trial at Memorial Sloan Kettering Cancer Center, commenting on LUMAKRAS FDA approval, said: “Sotorasib represents a major advancement in oncology and changes the treatment paradigm for patients with KRAS G12C-mutated non-small cell cancer.

“Patients with non-small cell cancer who have progressed beyond first-line treatment face a poor prognosis and have limited treatment options available to them. Sotorasib delivers a new option for these patients, and it is the first KRAS-targeted therapy to be approved after nearly four decades of research.”

is gearing up to conduct a global phase 3 clinical trial called CodeBreaK 200 to study sotorasib in comparison to docetaxel in patients having KRAS G12C-mutated NSCLC. The US biotech company said that it has wrapped up enrolment for the sotorasib phase 3 trial in NSCLC.

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