Braftovi FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 29, 2024.
FDA Approved: Yes (First approved June 27, 2018)
Brand name: Braftovi
Generic name: encorafenib
Dosage form: Capsules
Company: Pfizer Inc.
Treatment for: Melanoma, Metastatic, Colorectal Cancer, Non Small Cell Lung Cancer
Braftovi (encorafenib) is a kinase inhibitor used for the treatment of melanoma, colorectal cancer, and non-small cell lung cancer with BRAF mutations.
- Braftovi is indicated:
Melanoma
- in combination with Mektovi (binimetinib) for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Colorectal Cancer
- in combination with Erbitux (cetuximab) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
- in combination with Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) for the treatment of patients with metastatic CRC 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).
Non-Small Cell Lung Cancer
- in combination with Mektovi (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) 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.
Development timeline for Braftovi
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.