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KRAS G12C is the most common KRAS mutation in non-small cell lung cancer (NSCLC), which occurs in about 13% of patients.
year, about 33,000 new patients in the EU are diagnosed with the KRAS G12C mutation NSCLC.
because there is currently no approved KRAS G12C targeted therapy, the results of second-line treatment in these patients are often poor.
amgen has filed a listing application with the European Medicines Agency (EMA) seeking approval for the therapeutic treatment of KRAS G12C mutant non-small cell lung cancer (NSCLC), a research KRAS inhibitor.
phase II study (CodeBreaK 100) is evaluating the effectiveness of sotorasib in treating patients with KRAS G12C mutant NSCLC.
study, Sotorasib's objective mitigation rate was consistent with previously reported Phase I data.
more than half of the responders are still receiving treatment and are still responding as of the data deadline. "In the more than two years since the first patient started taking the drug, Sotorasib is on track to become the first targeted treatment for previously treated patients with non-small cell lung cancer with KRAS G12C mutations," said David M. Reese,
Amgen's vice president of research and executive vice president.
added: "By submitting an application to the EMA, AMS WILL will continue to rapidly advance the clinical program for KRAS G12C inhibitors."
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