AMGEN SUBMITS SOTORASIB NEW DRUG APPLICATION TO U.S. FDA FOR ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH KRAS G12C MUTATION
FDA Granted Breakthrough Therapy Designation for Sotorasib
Sotorasib Application Being Reviewed Under FDA Real-Time Oncology Review (RTOR) Pilot Program
THOUSAND OAKS, Calif., (Dec. 16, 2020) -- 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 KRASG12C inhibito