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Amgen Files for FDA Approval of Sotorasib for KRAS G12C-mutated NSCLC

NEW YORK – Amgen on Wednesday said it has submitted a new drug application to the US Food and Drug Administration for its KRAS inhibitor sotorasib as a treatment for previously treated, locally advanced, or metastatic non-small cell lung cancer patients whose tumors harbor KRAS G12C mutations.

The NDA submission contains data from the Phase II portion of the tumor-agnostic CodeBreak-100 clinical trial, which enrolled 126 previously treated, KRAS G12C-mutated NSCLC patients. Amgen will present detailed results from the study during the upcoming International Association for the Study of Lung Cancer (IASLC) conference in January 2021, but shared in October that more than half of the patients who responded to sotorasib remained on treatment and continued to respond as of the last data cutoff date.

The FDA will now review the data submitted by Amgen through its Real-Time Oncology Review program. The company is seeking approval for the drug for advanced or metastatic NSCLC patients who have received at least one prior line of systemic treatment and have tumors harboring KRAS G12C mutations as determined by an FDA-approved molecular test.  

"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 KRAS G12C mutation," David Reese, Amgen's executive VP of R&D, said in a statement, adding that roughly 13 percent of NSCLC patients harbor KRAS G12C mutations.