FDA Grants Accelerated Approval to Encorafenib/Cetuximab/Chemo Combo in BRAF V600E+ mCRC
The FDA granted accelerated approval to encorafenib, cetuximab, and mFOLFOX6 for mCRC with a BRAF V600E mutation. Data from the BREAKWATER trial showed a 61% ORR with the combination vs 40% with chemotherapy. Common adverse events included peripheral neuropathy and nausea. Encorafenib is recommended at 300 mg daily with cetuximab and mFOLFOX6.
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FDA Grants Accelerated Approval to Encorafenib/Cetuximab/Chemo Combo in BRAF V600E+ mCRC
The FDA granted accelerated approval to encorafenib, cetuximab, and mFOLFOX6 for mCRC with a BRAF V600E mutation. Data from the BREAKWATER trial showed a 61% ORR with the combination vs 40% with chemotherapy. Common adverse events included peripheral neuropathy and nausea. Encorafenib is recommended at 300 mg daily with cetuximab and mFOLFOX6.