Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy. The approval is based on results from the BEACON CRC trial, the only Phase 3 trial to specifically study patients with previously treated metastatic CRC with a BRAFV600E mutation.
“We are pleased by the FDA’s approval of BRAFTOVI in combination with cetuximab, as we are committed to developing targeted medicines that can help people living with certain mutation-driven cancers,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “We are grateful to the patients and study investigators who participated in the Phase 3 BEACON CRC trial and are proud to now be able to offer a targeted treatment option for people with BRAFV600E-mutant metastatic CRC who have received prior therapy. Looking ahead, we’re committed to continuing to investigate this treatment regimen across earlier lines of therapy.”
Based on results from the BEACON CRC trial, BRAFTOVI plus cetuximab showed a median overall survival (OS) of 8.4 months (95% CI: 7.5, 11.0) compared with 5.4 months (95% CI: 4.8, 6.6) for Control (irinotecan with cetuximab or FOLFIRI with cetuximab) ([HR 0.60, (95% CI: 0.45, 0.79), p=0.0003]). Additionally, BRAFTOVI plus cetuximab showed an improved objective response rate (ORR) of 20% (95% CI: 13%, 29%) compared with 2% (95% CI: 0%, 7%) for Control (p<0.0001) and median progression-free survival (mPFS) was 4.2 months with BRAFTOVI plus cetuximab (95% CI: 3.7, 5.4) versus 1.5 months with Control (95% CI: 1.4, 1.7) ([HR 0.40, (95% CI: 0.31, 0.52), p<0.0001]).
“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, M.D., Ph.D., 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 BRAFV600E-mutant metastatic CRC who have received prior therapy, BRAFTOVI in combination with cetuximab is a much-needed new treatment option for these patients.”
The most common adverse reactions (AR) (≥ 25%) seen in patients treated with BRAFTOVI in combination with cetuximab were fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia and rash.
The FDA granted this application Priority Review and Breakthrough Therapy designation. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists.
Pfizer is committed to ensuring that patients who are prescribed BRAFTOVI have access to this important treatment option. Pfizer is here to help patients in the U.S. understand their benefits and connect them with financial assistance resources for their prescribed Pfizer Oncology medicines.