Bristol Myers Squibb (BMS; NYSE: BMY) has submitted a priority review application to the U.S. Food and Drug Administration (FDA) for an additional indication of its KRASG12C inhibitor, Krazati (adagrasib), in combination with cetuximab (Merck’s Erbitux) for pre-treated patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA is expected to provide a response by June 21, 2024, after evaluating Phase I/II data that demonstrate a manageable safety profile and encouraging clinical efficacy.
Currently, Krazati enjoys conditional approvals in both Europe and the U.S. for treating KRASG12C-mutated locally advanced non-small cell lung cancer (NSCLC) following at least one prior systemic therapy. Additionally, it is in clinical trials for advanced KRASG12C-mutated solid tumors.- Flcube.com
