Reportedly, Amgen has submitted Marketing Authorization Application to the European Medicines Agency (EMA) for sotorasib, an investigational KRASG12C inhibitor for patients previously treated non-small-cell lung cancer (NSCLC) with the KRAS G12C Mutation.
The submission is backed by positive Phase 2 results in patients with locally advanced or metastatic NSCLC with KRAS G12C mutation whose cancer progressed even after chemotherapy and/or immunotherapy.
“Just over two years since the first patient was dosed, sotorasib is now on track to potentially be the first approved targeted therapy for patients with previously treated NSCLC harboring the KRAS G12C mutation,” “With this submission to EMA, Amgen is continuing to rapidly advance the KRASG12C inhibitor clinical program to bring this innovative potential therapy to patients globally as quickly as possible.” stated David M. Reese, M.D., executive vice president of Research and Development at Amgen.
KRAS G12C is the most common and known KRAS mutation in NSCLC.1. Approximately 13% of patients with NSCLC harbor the KRAS G12C mutation. Each year approximately 33,000 new patients in the EU-27 are diagnosed with KRAS G12C-mutated NSCLC.1,2.
Amgen has taken a tough challenge of the last 40 years in cancer research by developing sotorasib, an investigational KRASG12C inhibitor7, and the first KRASG12C inhibitor to enter the clinic. It is under study in the broadest clinical program exploring 10 combinations under global sites covering four continents. Sotorasib has shown a positive benefit-risk profile with deep, fast, and durable anti-cancer activity in patients with advanced non-small-cell lung cancer harboring the KRAS G12C mutation with a once-daily oral formulation.
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