FDA Grants Accelerated Approval to Pfizer's Braftovi Combination for Metastatic Colorectal Cancer
FDA grants Pfizer's Braftovi accelerated approval for BRAF V600E-mutant metastatic colorectal cancer, in combo with cetuximab and mFOLFOX6. BREAKWATER trial showed 61% ORR vs. 40% in control, with median DOR of 13.9 vs. 11.1 months. Common AEs include peripheral neuropathy, nausea, and fatigue.
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FDA Grants Accelerated Approval to Pfizer's Braftovi Combination for Metastatic Colorectal Cancer
FDA grants Pfizer's Braftovi accelerated approval for BRAF V600E-mutant metastatic colorectal cancer, in combo with cetuximab and mFOLFOX6. BREAKWATER trial showed 61% ORR vs. 40% in control, with median DOR of 13.9 vs. 11.1 months. Common AEs include peripheral neuropathy, nausea, and fatigue.