Regulatory approval
Published by the Food and Drug Administration.
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 is written in the approval document as:
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.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organization(s) | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| FDA (1) | BRAF p.V600E | Colorectal Adenocarcinoma | Cetuximab, Encorafenib, Fluorouracil, Oxaliplatin | |
| FDA (1) | BRAF p.V600E | Colorectal Adenocarcinoma | Cetuximab, Encorafenib, Fluorouracil, Irinotecan |