Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Cetuximab, Encorafenib, Fluorouracil, Oxaliplatin in patients with Colorectal Adenocarcinoma.
The U.S. Food and Drug Administration granted accelerated approval to encorafenib in combination with cetuximab and mFOLFOX6 for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. The package insert states that this indication is approved under accelerated approval based on response rate and durability of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Furthermore, it 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 mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC.