FDA Approves Braftovi, Erbitux Combo for BRAF V600E-Positive Metastatic CRC

April 9, 2020
Kristie L. Kahl

The Food and Drug Administration approved the combination use of Braftovi plus Erbitux for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation.

The Food and Drug Administration (FDA) approved the combination use of Braftovi (encorafenib) plus Erbitux (cetuximab) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation.

“BRAF mutations are estimated to occur in up to 15% of people with metastatic colorectal cancer and represent a poor prognosis for these patients,” Dr. Scott Kopetz, associate professor of gastrointestinal medical oncology at The University of Texas MD Anderson Cancer Center, in Houston, said in a press release. “As the first-and-only targeted regimen for people with BRAF V600E-mutant metastatic CRC who have received prior therapy, Braftovi in combination with cetuximab is a much-needed new treatment option for these patients.”

The agency based its decision on results from the randomized, active-controlled, open-label, multicenter phase 3 BEACON CRC trial, designed to specifically study patients with previously treated metastatic CRC with a BRAF V600E mutation.

The combination regimen improved overall survival (8.4 months versus 5.4 months), overall response rate (20% versus 2%) and median progression-free survival (4.2 months versus 1.5 months), compared with the control arm.

The most common side effects were fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia and rash.

Check back later for what you need to know about this approval.

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