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FDA Grants Priority Review to Encorafenib/Cetuximab Combo for BRAF+ mCRC

Gina Columbus @ginacolumbusonc
Published: Wednesday, Dec 18, 2019

Chris Boshoff, MD, PhD

Chris Boshoff, MD, PhD
The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for the combination of encorafenib (Braftovi) and cetuximab (Erbitux) as a treatment for patients with advanced BRAF V600E–mutant metastatic colorectal cancer (mCRC) following up to 2 prior lines of therapy.1

The designation 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.2 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.

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