Amgen submits sotorasib MAA to the European Medicines Agency for treatment of patients with previously treated KRAS G12C-mutated locally advanced or metastatic (NSCLC).

Amgen announced submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotorasib, a non-small cell lung cancer (an investigational KRASG12C inhibitor, for the treatment of adult patients with previously treated KRAS G12C-mutated locally advanced or metastatic (NSCLC). KRAS G12C is the most common KRAS mutation in NSCLC. Approximately 13% of patients with NSCLC harbor the KRAS G12C mutation and each year approximately 33,000 new patients in the EU-27 are diagnosed with KRAS G12C-mutated NSCLC.There is a high unmet need and poor outcomes in the second-line treatment of KRAS G12C-driven NSCLC and, currently, there are no KRAS G12C targeted therapies approved. The submission is supported by positive Phase II results in patients with locally advanced or metastatic NSCLC with KRAS G12C mutation from the CodeBreaK 100 clinical study, whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. In the Phase 1 study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk profile. These results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Presidential Symposium in January 2021.