The Food and Drug Administration has withdrawn the accelerated approval of Krazati (adagrasib) in combination with Erbitux (cetuximab) for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer who have previously been treated with a fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimen. The withdrawal took effect September 1, 2026, according to the FDA’s list of withdrawn cancer accelerated approvals and the FDA approval letter published in the agency’s drug documents system.
The accelerated approval was originally granted in June 2024. According to the FDA approval letter, the sponsor requested voluntary withdrawal of the indication and waived the expedited withdrawal procedures set forth in the Food, Drug, and Cosmetic Act. The withdrawal closes the postmarketing requirements and postmarketing commitments that had been attached to the original accelerated approval.
The decision follows final results from the Phase 3 KRYSTAL-10 trial (NCT04793958), the confirmatory study that the FDA had required to verify the combination’s clinical benefit. According to the trade coverage of the results, KRYSTAL-10 randomly assigned 461 patients with KRAS G12C-mutated metastatic colorectal cancer whose disease had progressed after first-line chemotherapy to receive adagrasib plus cetuximab or investigator’s choice of chemotherapy. The trial did not demonstrate a statistically significant improvement in either progression-free survival or overall survival compared with chemotherapy, and the results were presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2026.
Accelerated approval is a pathway that allows the FDA to approve drugs that treat serious conditions and fill an unmet medical need on the basis of surrogate or intermediate endpoints, subject to a confirmatory trial. When a confirmatory trial does not verify clinical benefit, the FDA can withdraw the accelerated approval. According to the FDA approval letter, resuming marketing for the withdrawn indication would require the sponsor to obtain approval of an efficacy supplement.
The withdrawal applies only to the specific combination indication in KRAS G12C-mutated colorectal cancer. Other indications for adagrasib and other approved combinations of the two drugs are not affected by this action, according to the FDA notice.
