What is Braftovi used to treat?
Braftovi is used in combination with other drugs to treat patients with advanced melanoma, advanced non-small cell lung cancer and advanced colorectal cancer with BRAF gene mutations.
Braftovi is an oral small molecule BRAF kinase inhibitor.
Melanoma
Braftovi (encorafenib) is used 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.
Roughly 50% of patients diagnosed with metastatic melanoma test positive for the BRAF mutation, and it is the most common genetic mutation in metastatic melanoma.
Braftovi is not indicated for the treatment of patients with wild-type BRAF melanoma.
Colorectal Cancer
Braftovi is used 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.
Braftovi is also used in combination with Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) for the first-line treatment of patients with metastatic colorectal cancer 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).
BRAF mutations are estimated to occur in up to 15% of people with metastatic colorectal cancer.
Braftovi is not indicated for treatment of patients with wild-type BRAF CRC.
Non-Small Cell Lung Cancer
Braftovi is used 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.
BRAF mutations are estimated to occur in 2% to 5% of people with metastatic non-small cell lung cancer.
Braftovi is not indicated for the treatment of patients with wild-type BRAF NSCLC.
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References
- Braftovi (encorafenib) prescribing information. Revised 12/2024. Pfizer Inc. New York, NY. Accessed Dec 29, 2024 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210496s017lbl.pdf
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