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FDA Approves BMS's Krazati With Cetuximab for KRAS G12C-Mutated Colorectal Cancer

NEW YORK – The US Food and Drug Administration has granted accelerated approval to Bristol Myers Squibb's Krazati (adagrasib) plus Eli Lilly's EGFR inhibitor Erbitux (cetuximab) for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer.

The drug has been approved for patients who received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Eligible patients must test positive for KRAS G12C-mutated locally advanced or metastatic CRC using an FDA-approved test, the agency noted on Friday.

The accelerated approval was based on the results of the KRYSTAL-1 study, a multicenter, single-arm expansion cohort trial.

Pooled results from that study were presented by Scott Kopetz, deputy chair of translational research at MD Anderson Cancer Center's gastrointestinal medical oncology department, in April at the American Association for Cancer Research annual meeting and were simultaneously published in Cancer Discovery.

Out of the 94 patients who received the recommended dose of Krazati combined with Erbitux in this pooled analysis, 34 percent responded to the combination. The disease control rate, which includes patients whose tumors shrank and those with stable disease, was 85.1 percent. Median progression-free survival was 6.9 months and median overall survival was 15.9 months. After six months of treatment, 87.8 percent of patients were still alive.

Krazati was developed by Mirati Therapeutics, which was acquired by Bristol Myers Squibb last year. BMS said in February it had submitted a supplemental new drug application to the FDA seeking approval for Krazati plus Erbitux in this patient population, and the FDA was expected to make a decision on this application by today.