Amgen seeks marketing authorization for lung cancer therapy in Europe

 

• Amgen (NASDAQ:AMGN) has submitted the marketing authorization application to the European Medicines Agency for sotorasib in locally advanced or metastatic non-small cell lung cancer in adults.
• Aotorasib, an investigational KRASG12C inhibitor with a once-daily oral formulation, has demonstrated a positive benefit-risk profile with fast, deep, and durable anti-cancer activity in advanced NSCLC with KRAS G12C mutation, a statement from the company stated.
• The submission is backed by positive Phase 2 results for sotorasib from the CodeBreaK 100 clinical study involving previously treated patients with locally advanced or metastatic NSCLC with KRAS G12C mutation.
• The most common KRAS mutation in NSCLC, KRAS G12C mutation, is found in 13% of patients with NSCLC with no approved KRAS G12C targeted therapies.
• “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,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
• The European submission for marketing authorization comes days after the company’s New Drug Application was submitted to the FDA for sotorasib in NSCLC.
• https://seekingalpha.com/news/3646668-amgen-seeks-marketing-authorization-for-lung-cancer-therapy-in-europe