Amgen Submits Sotorasib Marketing Authorization Application To The European Medicines Agency
KRAS G12C Mutation
EU Application Follows Sotorasib New Drug Application Submission to U.S. FDA Announced Last Week
THOUSAND OAKS, California, Dec. 22, 2020 /PRNewswire/ Amgen (NASDAQ: AMGN) today announced submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotorasib, an investigational KRAS
G12C inhibitor, for the treatment of adult patients with previously treated
KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). 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
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THOUSAND OAKS, Calif., Dec. 16, 2020 /PRNewswire/ Amgen (NASDAQ:AMGN) today announced submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sotorasib, an investigational KRAS
G12C inhibitor for the treatment of patients with
KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, following at least one prior systemic therapy. Sotorasib was the first KRAS
G12C inhibitor to enter the clinic and now is on track to potentially be the first approved targeted therapy for patients with advanced NSCLC harboring the