Scott Kopetz, MD at MD Anderson discusses the FDA Approval Encorafenib) In Combination With Cetuximab For The Treatment Of Brafv600E-Mutant Metastatic Colorectal C
Based on BEACON CRC test results, BRAFTOVI plus cetuximab showed a median overall survival ( OS) of 8.4 months (95 percent CI: 7.5, 11.0) compared to 5.4 months (95 percent CI: 4.8, 6.6) for Control (cetuximab irinotecan or cetuximab FOLFIRI) ([HR 0.60, (95 percent CI: 0.45, 0.79), p=0.0003]). In addition, BRAFTOVI plus cetuximab showed an improved target response rate (ORR) of 20 percent (95 percent CI: 13 percent, 29 percent ) compared to 2 percent (95 percent CI: 0 percent, 7 percent) for Control (p<0.0001) and average progression-free survival (mPFS) of 4.2 months for BRAFTOVI plus cetuximab (95 percent CI: 3.7, 5.4) compared to 1.5 months for Control (95 percent CI: 1.4 percent CI: 1.4 percent).
Fatigue, nausea , diarrhea, dermatitis acneiform, stomach pain, reduced appetite, arthralgia and rash were the most common adverse reactions (AR) (about 25 percent) seen in patients treated with BRAFTOVI in conjunction with cetuximab. You will find the full prescription information for BRAFTOVI here.
The FDA gave priority review and classification of the breakthrough therapy to this submission. In the absence of appropriate therapy, the FDA gives Priority Review to drugs that may provide substantial improvements in care or may provide therapy.