NDAORALCAPSULE
Approved
Jun 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
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. Approved for melanoma, colorectal cancer. First approved in 2018.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BRAFTOVI (encorafenib) is an oral BRAF kinase inhibitor approved in June 2018 for treating BRAF-mutant melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). The drug works by potently inhibiting constitutively activated BRAF kinases (particularly BRAF V600E mutations) with IC50 values of 0.35 nM, suppressing the RAF/MEK/ERK pathway that drives tumor cell growth. BRAFTOVI is typically combined with binimetinib (a MEK inhibitor) or cetuximab (an EGFR inhibitor) to enhance efficacy and overcome resistance mechanisms.
$0.1BPart D
7.3 years to LOEMechanism 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 (2)
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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.