NDAORALCAPSULE
Approved
Jun 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
BRAFTOVI (encorafenib) by Pfizer is v600e, as well as wild-type braf and craf in in vitro cell-free assays with ic 50 values of 0. First approved in 2018.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BRAFTOVI (encorafenib) is an oral BRAF kinase inhibitor that selectively targets mutated BRAF V600E, V600D, and V600K mutations in cancer cells. It is primarily used to treat BRAF-mutant melanoma, NSCLC, and colorectal cancer, often in combination with MEK or EGFR inhibitors to overcome resistance mechanisms. The drug works by suppressing the RAF/MEK/ERK pathway that drives tumor cell proliferation in BRAF-mutant cancers.
$87MPart D
Peak7.1 years to LOEThe product is at peak lifecycle stage with modest Part D spending ($87M) and established commercial operations, suggesting stable team size and mature go-to-market execution.
Mechanism of Action
V600E, as well as wild-type BRAF and CRAF in in vitro cell-free assays with IC 50 values of 0.35, 0.47, and 0.3 nM, respectively. Mutations in the BRAF gene, such as BRAF V600E, can result in constitutively activated BRAF kinases that may stimulate tumor cell growth. Encorafenib was also able to…
Indications
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.