FDA Grants Accelerated Approval to Encorafenib Combination for BRAF V600E–Mutant ...

FDA granted accelerated approval to encorafenib (Braftovi) with cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation. Efficacy was confirmed in the BREAKWATER trial, showing 61% objective response rate in the treatment arm vs. 40% in the control arm. Common adverse reactions include peripheral neuropathy and nausea. Recommended dose is 300 mg of encorafenib daily with cetuximab and mFOLFOX6.


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FDA Grants Accelerated Approval to Encorafenib Combination for BRAF V600E–Mutant ...

FDA granted accelerated approval to encorafenib (Braftovi) with cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation. Efficacy was confirmed in the BREAKWATER trial, showing 61% objective response rate in the treatment arm vs. 40% in the control arm. Common adverse reactions include peripheral neuropathy and nausea. Recommended dose is 300 mg of encorafenib daily with cetuximab and mFOLFOX6.

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