The Food and Drug Administration (FDA) has approved Braftovi® (encorafenib; Pfizer) in combination with cetuximab (Erbitux®; Lilly) 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.

The approval was based on results from the multicenter, open-label, phase 3 BEACON trial in adult patients with BRAF V600E mutation-positive metastatic CRC with disease progression after 1 or 2 prior regimens. Patients were randomized 1:1:1 to receive: Braftovi 300mg orally once daily in combination with cetuximab (n=220) or with cetuximab plus binimetinib, or irinotecan with cetuximab or FOLFIRI with cetuximab (n=221; control arm). The primary efficacy end point was overall survival (OS); additionally efficacy end points included progression-free survival (PFS), overall response rate (ORR), and duration of response (DoR).

Findings showed that Braftovi plus cetuximab demonstrated a median OS of 8.4 months (95% CI, 7.5-11.0) compared with 5.4 months (95% CI, 4.8-6.6) for the control arm (HR 0.60; 95% CI, 0.45-0.79; P =.0003). In addition, compared with the control arm, Braftovi plus cetuximab showed an improved ORR (20% [95% CI, 13-29] vs 2% [95% CI, 0-7]; P <.0001) and median PFS (4.2 months vs 1.5 months; HR 0.40; 95% CI, 0.31-0.52; P <.0001).

Regarding safety, the most common adverse reactions (≥ 25%) reported for Braftovi plus cetuximab included fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia and rash. 

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BRAF mutations are estimated to occur in up to 15% of people with metastatic colorectal cancer and represent a poor prognosis for these patients,” said Scott Kopetz, MD, PhD, FACP, Associate Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. “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.”

Braftovi, a kinase inhibitor, is already indicated in combination with binimetinib, for the treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. The product is supplied as 75mg hard gelatin capsules.

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