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FDA Approves Encorafenib/Cetuximab Combo for BRAF+ mCRC

Jason M. Broderick @jasoncology
Published: Wednesday, Apr 08, 2020

The FDA has approved the combination of encorafenib (Braftovi) and cetuximab (Erbitux) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.1

The approval is based on findings from the phase III BEACON CRC study, which evaluated encorafenib plus cetuximab with or without binimetinib (Mektovi) in this patient population. Results showed that both the doublet and triplet approaches demonstrated an improvement in overall survival (OS) as well as objective response rates (ORRs) versus cetuximab plus irinotecan-containing regimens.

Findings from the study published in 2019 in the New England Journal of Medicine showed that, after a median follow-up of 7.8 months, the median OS was 9.0 months in the triplet arm versus 5.4 months in the control group (HR, 0.52; 95% CI, 0.39-0.70; P <.001).2 The median OS in the doublet arm was 8.4 months (HR vs control, 0.60; 95% CI, 0.45-0.79; P = .0003).

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