Pfizer announced that the U.S. FDA has approved Braftovi in combination with Erbitux for the treatment of adult patients with BRAF-mutant metastatic colorectal cancer.
The FDA had granted the application Priority Review and Breakthrough Therapy designation. The approval is based on positive results from the BEACON CRC trial, the only Phase 3 trial to specifically study patients with previously treated metastatic CRC with a BRAFV600E mutation.
BRAF mutations are estimated to occur in up to 15 percent of people with metastatic colorectal cancer.
"As the first-and-only targeted regimen for people with BRAFV600E-mutant metastatic CRC who have received prior therapy, Braftovi in combination with cetuximab is a much-needed new treatment option for these patients," said Scott Kopetz, M.D., Ph.D., FACP, Associate Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center.
Read the press release
