Binimetinib is a prescription medicine indicated in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test, among other approved uses. MedsAcross supplies Binimetinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
MEKTOVI is a kinase inhibitor indicated: • in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. • in combination with encorafenib, 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.
Source: US FDA prescribing information
Binimetinib is a reversible inhibitor of 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 viability and MEK-dependent phosphorylation of BRAF-mutant human melanoma cell lines. Binimetinib also inhibited in vivo ERK phosphorylation and tumor growth in BRAF-mutant murine xenograft models. Binimetinib and encorafenib target two different kinases in the RAS/RAF/MEK/ERK pathway.
Source: US FDA prescribing information
Melanoma • Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to the initiation of MEKTOVI. • The recommended dose is 45 mg orally twice daily in combination with encorafenib. Take MEKTOVI with or without food. • For patients with moderate or severe hepatic impairment the recommended dose is 30 mg orally twice daily. NSCLC • Confirm the presence of BRAF V600E mutation in tumor or plasma specimens prior to initiating MEKTOVI. • The recommended dose is 45 mg orally twice daily in combination with encorafenib. Take MEKTOVI with or without food.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
• New Primary Malignancies, Cutaneous and Non-cutaneous: Can occur when MEKTOVI is used in combination with encorafenib. Monitor patients for new malignancies prior to initiation of treatment, during treatment, and after discontinuation of treatment. • Cardiomyopathy: Assess left ventricular ejection fraction (LVEF) before initiating treatment, after one month of treatment, then every 2 to 3 months thereafter. The safety of MEKTOVI has not been established in patients with LVEF below 50%. • Venous Thromboembolism: Deep vein thrombosis and pulmonary embolism can occur. • Ocular Toxicities: Serous retinopathy, retinal vein occlusion (RVO) and uveitis have occurred. Perform an ophthalmologic evaluation at regular intervals and for any visual disturbances. • Interstitial Lung Disease (ILD): Assess new or progressive unexplained pulmonary symptoms or findings for possible ILD.
Source: US FDA prescribing information
The following adverse reactions are described elsewhere in the labeling: • New Primary Malignancies • Cardiomyopathy • Venous Thromboembolism • Ocular Toxicities • Interstitial Lung Disease • Hepatotoxicity • Rhabdomyolysis • Hemorrhage • Embryo-Fetal Toxicity • Risks Associated with Combination Treatment Melanoma: Most common adverse reactions (≥25%) for MEKTOVI, in combination with encorafenib, are fatigue, nausea, diarrhea, vomiting, and abdominal pain. NSCLC: Most common adverse reactions (≥25%) for MEKTOVI, in combination with encorafenib, are fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough.
Source: US FDA prescribing information
No clinically important drug interactions have been observed with MEKTOVI.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Binimetinib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Mektovi 15 mg tabletOral | Array BioPharma | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Binimetinib in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Binimetinib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Binimetinib, including Mektovi.
Yes. The US FDA first approved Binimetinib on 27 June 2018, according to Drugs@FDA.
Yes. Binimetinib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Binimetinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Binimetinib is classified under ATC code L01EE03 (Binimetinib).
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