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FDA Approves Braftovi, Erbitux Combination for BRAF V600E-Mutated Colorectal Cancer Patients

NEW YORK – The US Food and Drug Administration approved encorafenib (Pfizer/Array BioPharma's Braftovi) on Thursday in combination with cetuximab (Eli Lilly's Erbitux) for BRAF V600E-Mutated metastatic colorectal patients. The drug combination is intended for those who have received prior therapy and have their BRAF mutation status detected by an FDA-approved test.

The approval was supported by data from a randomized Phase III BEACON trial, which enrolled BRAF-mutated patients who progressed on one or two prior treatments. During the trial, patients had their mutation status verified by the Qiagen therascreen BRAF V600E RGQ PCR kit. Ultimately, 220 patients were randomized to receive treatment with encorafenib and cetuximab, and 221 patients were allocated to the control arm, receiving either chemotherapies irinotecan or FOLFIRI with cetuximab. 

The study saw an overall response rate of 20 percent in the encorafenib arm compared to 2 percent in the control arm. Median overall survival was 8.4 months in the treatment arm compared to 5.4 months in the control arm. Median progression-free survival was 4.2 months in the treatment arm and 1.5 months in the control arm. Median duration of response was not reached at the time of data collection in the control arm and was 6.1 months in the treatment arm.

In the trial, the most common adverse reactions that arose in response to the encorafenib and cetuximab combination were fatigue, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash.

With this approval, encorafenib becomes the first and only targeted drug for patients with BRAF-mutated metastatic colorectal cancer who have received prior therapy. BRAF mutations occur in up to 15 percent of metastatic colorectal cancers and is usually associated with a poor prognosis.

Pfizer acquired Array BioPharma in 2019 and has exclusive rights to encorafenib in the US and Canada.