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Treats unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. Sold as Braftovi. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Encorafenib (sold as Braftovi), first approved Jun 27, 2018, with 9 new uses approved and 0 published complete response letters.
First approved: Jun 27, 2018
Applications: 1
New uses approved: 9
Complete response letters: 0
Medicare spending, 2025: $234M
Orphan exclusivity until: Oct 11, 2030
First approved in the EU: Sep 19, 2018
First approved in Japan: Jan 8, 2019
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 6 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
BraftoviDrugs with a new indication and a new dosage for the treatment of unresectable, advanced or recurrent BRAF mutation-positive colorectal cancer. · Ono Pharmaceutical Co., Ltd. · Nov 20, 2025
BraftoviDrugs with new indications and a new dosage for the treatments of unresectable BRAF mutation-positive thyroid cancer that has progressed after cancer… · Ono Pharmaceutical Co., Ltd. · May 17, 2024
BraftoviDrugs with a new indication and a new dosage for the treatment of unresectable, advanced or recurrent BRAF mutation-positive colorectal cancer that has… · Ono Pharmaceutical Co., Ltd. · Nov 27, 2020 · Review report
Braftovi, new ingredientA drug with a new active ingredient indicated for the treatment of unresectable melanoma with BRAF gene mutation. · Ono Pharmaceutical Co., Ltd. · Jan 8, 2019 · Review report
Clinical Trials
46 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
