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FDA Grants Accelerated Approval to BMS's Krazati in Combination with Cetuximab for KRAS G12C-Mutated Colorectal Cancer

NextEdge Admin

22 Jun 2024

2 min 50 sec

Bristol Myers Squibb's Krazati (adagrasib), in combination with Eli Lilly's EGFR inhibitor Erbitux (cetuximab), has received accelerated approval from the US Food and Drug Administration (FDA) for treating adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC). This approval applies specifically to patients who have previously undergone fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and who test positive for the KRAS G12C mutation using an FDA-approved test.

The decision by the FDA follows findings from the KRYSTAL-1 study, a multicenter, single-arm expansion cohort trial. Scott Kopetz, from MD Anderson Cancer Center, presented pooled results from this study at the American Association for Cancer Research annual meeting and concurrently published them in Cancer Discovery.

According to the pooled analysis, 94 patients who received the recommended dose of Krazati combined with Erbitux showed promising outcomes. Approximately 34 percent of patients responded to the treatment combination, while the disease control rate (including patients with tumor shrinkage and stable disease) was 85.1 percent. Median progression-free survival was reported at 6.9 months, and median overall survival was 15.9 months. Notably, after six months of treatment, 87.8 percent of patients were still alive.

Mirati Therapeutics initially developed Krazati, which Bristol Myers Squibb acquired last year. In February, Bristol Myers Squibb submitted a supplemental new drug application to the FDA seeking approval for Krazati plus Erbitux in this specific patient population. The FDA's decision, anticipated by a certain date, aligned with this recent approval.

The accelerated approval signifies an important advance for patients with KRAS G12C-mutated CRC who have exhausted standard chemotherapy options. It underscores the potential of targeted therapies like Krazati in addressing specific genetic mutations driving cancer progression, offering new hope in the treatment landscape for this challenging condition.