FDA Approves Sotorasib (Lumakras) for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cel

On May 28, 2021, Amgen announced that the U.S. Food and Drug Administration (FDA) has approved Sotorasib (Lumakras) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have received at least one prior systemic therapy. Sotorasib (Lumakras) received accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Dr. David M. Reese, Executive Vice President of Research and Development at Amgen, stated: "The FDA approval of Sotorasib (Lumakras) is a breakthrough moment for patients with KRAS G12C-mutated non-small cell lung cancer, as there is now a targeted therapy available for this common but previously difficult-to-target mutation. For over 40 years, KRAS has been a challenge for cancer researchers, with many considering it 'undruggable.' The development program for Sotorasib (Lumakras) was a race against cancer for Amgen's scientists and clinical trial investigators, who worked together to successfully bring this new medicine to patients in less than three years—from first patient dosing to U.S. regulatory approval."

Dr. Bob T. Li, M.D., Ph.D., M.P.H., lead investigator at Memorial Sloan Kettering Cancer Center, commented: "Sotorasib represents a significant advancement in oncology, transforming the treatment paradigm for patients with KRAS G12C-mutated non-small cell lung cancer. Patients with non-small cell lung cancer who progress after first-line therapy have a poor prognosis and limited treatment options. Sotorasib offers a new option for these patients, being the first KRAS-targeted therapy approved in nearly four decades."

About Sotorasib (Lumakras)

Amgen developed Sotorasib (Lumakras) as a KRAS G12C inhibitor, overcoming one of the most formidable challenges in cancer research over the past 40 years. Sotorasib (Lumakras) is the first KRAS G12C inhibitor to enter clinical development and is currently part of the largest clinical program, exploring 11 combination regimens across research institutions on five continents.

Sotorasib (Lumakras) is formulated as a once-daily oral tablet and has demonstrated a favorable benefit-risk profile in patients with locally advanced and metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation, showing rapid, potent, and durable anticancer activity. As part of this accelerated approval evaluation, the U.S. Food and Drug Administration (FDA) has required a post-marketing trial to investigate whether a lower dose would produce similar clinical effects.

Sotorasib Studied in Other Solid Tumors

In the United States, Sotorasib (Lumakras) was reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program, designed to explore a more efficient review process and ensure that safe and effective treatments are available to patients as early as possible. Amgen submitted a Marketing Authorization Application (MAA) in the European Union in December 2020, a New Drug Application (J-NDA) in Japan in April 2021, and has also submitted applications in Switzerland. Additionally, in January 2021, Amgen submitted marketing authorization applications for Sotorasib in Australia, Brazil, Canada, and the United Kingdom to participate in the FDA's Project Orbis. Sotorasib has received Breakthrough Therapy Designation in both the United States and China.