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On May 28, 2021, Amgen announced that the U.S. Food and Drug Administration (FDA) had approved sotorasib (Lumakras) for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) harboring a KRAS G12C mutation 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 a confirmatory trial.
Dr. David M. Reese, Executive Vice President of Research and Development at Amgen, stated:
“The FDA approval of sotorasib (Lumakras) represents a breakthrough moment for patients with KRAS G12C‑mutated non‑small cell lung cancer, as we now have a targeted therapy for this common, yet historically difficult‑to‑treat mutation. For more than 40 years, KRAS has been a challenge for cancer researchers, with many considering it ‘undruggable’. The sotorasib (Lumakras) program was a race against cancer for Amgen scientists and clinical investigators, who worked together to successfully deliver this new medicine to patients in less than three years—from the first patient dosed to U.S. regulatory approval.”
Dr. Bob T. Li, MD, PhD, MPH, Lead Investigator at Memorial Sloan Kettering Cancer Center, noted:
“Sotorasib represents a major advance in oncology that has changed the treatment paradigm for patients with KRAS G12C‑mutated non‑small cell lung cancer. Patients with NSCLC whose disease progresses after first‑line therapy have a poor prognosis and limited treatment options. Sotorasib provides these patients with a new option and is the first approved KRAS‑targeted therapy in nearly four decades.”
About Sotorasib (Lumakras)
Amgen discovered sotorasib (Lumakras), a KRAS G12C inhibitor, addressing one of the most formidable challenges in cancer research over the past 40 years. Sotorasib (Lumakras) was the first KRAS G12C inhibitor to enter the clinic and is currently being evaluated in the largest clinical development program of its kind, exploring 11 combination regimens across global institutions on five continents.
Administered as an oral, once‑daily tablet, sotorasib (Lumakras) demonstrates a favorable benefit‑risk profile with rapid, potent, and durable anticancer activity in patients with locally advanced and metastatic NSCLC harboring a KRAS G12C mutation. As part of the accelerated approval evaluation, the FDA has required a post‑marketing trial to investigate whether a lower dose results in similar clinical outcomes.
Sotorasib in Other Solid Tumors
In the U.S., sotorasib (Lumakras) was reviewed under the FDA’s Real‑Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective therapies reach 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 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 U.S. and China.
