FDA approves Braftovi + cetuximab for BRAFV600E-mutant metastatic CRC indication

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA has approved Braftovi (encorafenib) in combination with Erbitux (cetuximab) for the treatment of adult patients with metastatic colorectal cancer 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 III trial to specifically study patients with previously treated metastatic CRC with a BRAFV600E mutation.

Braftovi is sponsored by Pfizer.

Based on results from the BEACON CRC trial, Braftovi plus cetuximab showed a median overall survival 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,”Scott Kopetz, associate professor of gastrointestinal medical oncology at MD Anderson Cancer Center, said in a statement. “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 full prescribing information for BRAFTOVI can be found here.

Table of Contents

YOU MAY BE INTERESTED IN

Candace S. Johnson leads America’s oldest cancer research center and Jonathan W. Friedberg leads the newest NCI-designated center. Their catchment areas are contiguous, their faculty and staff members collaborate often, and together their institutions embody the culture of NCI-designated cancer centers. 

In the first meeting of the National Cancer Advisory Board since the inauguration of President Donald Trump, NCI Principal Deputy Director Douglas R. Lowy addressed many of the burning questions the oncology field has for the institute. On indirect costs: NCI will continue to use previously negotiated and approved indirect cost rates, with the exception...

The Cancer Letter staff were finalists for nine 2025 Dateline Awards from the Washington, D.C. Chapter of the Society of Professional Journalists—seven for journalism; two for design—and won first place for four. The Cancer Letter’s entries recognized by SPJ include investigative journalism, series, breaking news, features, photojournalism, commentary, illustration, and front page design. This is...

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login