FDA accepts supplemental NDA for Krazati (adagrasib) + cetuximab to treat patients with previously treated KRAS G12C-mutated locally advanced or metastatic colorectal cancer

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024.

“Pretreated KRASG12C-mutated CRC is associated with poor outcomes and the current standard of care offers limited clinical benefit for patients,” said Anne Kerber, senior vice president, head of late clinical development, Hematology, Oncology, Cell Therapy (HOCT) at Bristol Myers Squibb. “The acceptance of this filing for Krazati in combination with cetuximab is a positive step toward providing a potential new option for patients and their physicians. It reinforces our commitment to developing potentially transformative targeted cancer therapies for patients for whom few treatment options exist.”

The submission is based on the results of KRYSTAL-1 study, a multicohort trial which evaluated Krazati alone or in combination with other anticancer therapies in patients with advanced solid tumors harboring a KRASG12C mutation. The primary endpoint for the registrational cohort was objective response rate. The secondary endpoints for the pooled cohorts included duration of response, progression-free survival, overall survival and safety. Results of the KRYSTAL-1 study showed that Krazati was well tolerated and provided promising clinical activity in pretreated patients with locally advanced or metastatic CRC harboring a KRASG12C mutation. The safety profile for Krazati plus cetuximab was manageable and consistent with previous reports, and with the known safety profile of each drug individually.