NDAORALTABLET
Approved
Jun 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
MEKTOVI (binimetinib) by Pfizer is mitogen-activated extracellular signal regulated kinase 1 (mek1) and mek2 activity. First approved in 2018.
Drug data last refreshed 2d ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MEKTOVI (binimetinib) is an oral small-molecule MEK1/2 inhibitor approved by the FDA in June 2018 for BRAF-mutant melanoma and non-small cell lung cancer. It works by blocking the MEK proteins in the RAS/RAF/MEK/ERK signaling pathway, inhibiting tumor cell proliferation and growth. The drug is typically used in combination with encorafenib (a BRAF inhibitor) to achieve synergistic anti-tumor activity and delay resistance emergence.
$0.057BPart D
Peak7.3 years to LOEProduct is at commercial peak with ~$57M annual Medicare Part D spending; team likely stable in size with focus on maximizing existing indication penetration.
Mechanism of Action
mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activity. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway. In vitro, binimetinib inhibited extracellular signal-related kinase (ERK) phosphorylation in cell-free assays as well as…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Surgical or Radiotherapeutic Intervention Concerning Large Singular Stable to Progressive Metastases in Patients With BRAFV600-mutated Melanoma Receiving Treatment With Encorafenib + Binimetinib
Started Aug 2025
0Melanoma BRAF V600E/K Mutated
UK ENcorafenib and BInimetinib Real-world Study in Melanoma
Started Jul 2025
50 enrolled
Metastatic Melanoma, BRAF V600 Mutation Positive
Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases
Started May 2025
33 enrolled
Melanoma BRAF V600E/K MutatedMelanoma and Brain Metastases
Study to Evaluate the Efficacy and Safety of Cetuximab in Combination with Encorafenib Plus Binimetinib As Induction Treatment in BRAF V600E Mutated MSS Initially Resectable or Potentially Resectable Advanced Colorectal Cancer
Started Apr 2024
70 enrolled
Colorectal Cancer
A Study to Compare How Effective is Encorafenib Plus Binimetinib in Real-world and Clinical Trial Settings
Started Jul 2023
275 enrolled
Metastatic Melanoma
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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.