Sotorasib Receives FDA Priority Review for KRAS G12C–Mutated Advanced Lung Cancer
Posted: Friday, February 19, 2021
On February 16, the U.S. Food and Drug Administration (FDA) granted Priority Review to the first-in-class KRAS G12C inhibitor sotorasib to treat patients with KRAS G12C-mutated locally advanced or metastatic non–small cell lung cancer (NSCLC) after one prior systemic therapy.
The Priority Review was based on the results of the open-label multicenter phase II CodeBreak 100 clinical trial. The study enrolled 126 patients with KRAS G12C–mutant solid tumors who had received a prior line of systemic therapy consistent with their tumor type and stage of disease. About 124 patients also had centrally evaluable lesions by Response Evaluation Criteria in Solid Tumors at baseline. The primary endpoint was centrally assessed objective response rate.
An upcoming global phase III active-controlled trial will be recruiting patients with KRAS G12C–mutant NSCLC to compare sotorasib with docetaxel.
