Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Cetuximab, Encorafenib, Fluorouracil, Irinotecan in patients with Colorectal Adenocarcinoma.
The U.S. Food and Drug Administration granted accelerated approval to encorafenib in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. This approval was based on NCT04607421, a randomized, active-controlled, open-label, multicenter trial. Braftovi was initially evaluated in combination with cetuximab and mFOLFOX6 and later in combination with cetuximab and FOLFIRI, and the two treatment arms observed an objective response rate of 61% and 64%, respectively. The package insert states that encorafenib's package insert further states that it is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF non-small cell lung cancer.
This statement is based on a regulatory approval from the Food and Drug Administration:
BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC.