Bristol Myers announces FDA accelerated approval of Krazati for CRC

Bristol Myers Squibb announced that the Food and Drug Administration has granted accelerated approval for Krazati in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C -mutated locally advanced or metastatic colorectal cancer, or CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on objective response rate, or ORR, and duration of response, or DOR, results. Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial, Bristol Myers noted. In 2022, the FDA granted breakthrough therapy designation for Krazati in combination with cetuximab for patients with KRASG12C -mutated advanced CRC whose cancer has progressed following prior treatment with certain chemotherapy and an anti-VEGF therapy. “Today’s approval of KRAZATI in CRC is the second in the U.S. for this therapy and the first for BMS’ recently expanded oncology portfolio. This is an important milestone for BMS and the patients we serve as we deliver on our commitment to provide innovative medicines for cancer. We are proud to make KRAZATI – the first KRASG12C inhibitor to be FDA approved beyond non-small cell lung cancer – available to CRC patients, and look forward to further evaluating KRAZATI through our ongoing development program,” said Wendy Short Bartie, senior vice president, U.S. Oncology and Hematology at Bristol Myers Squibb.