OnCo
drugsProductApproved2018🇪🇺🇬🇧🇯🇵🇦🇺

Binimetinib

Binimetinib is the MEK inhibitor partnered with encorafenib; blocking the next step in the same relay stops the tumour rerouting around the BRAF block.

Approved June 2018 with encorafenib for BRAF V600 melanoma (COLUMBUS) and 2023 for BRAF V600E NSCLC. Class effects: retinopathy (serous retinal detachment), CK elevation, left-ventricular dysfunction, rash, diarrhoea.

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Binimetinib
PubChem
Mechanism, step by step
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1.Binds MEK1/2 outside the ATP site and locks them in an inactive conformation

Modality
Small-molecule kinase inhibitor (MEK1/2)
Mechanism
Allosteric, ATP-non-competitive MEK1/2 inhibitor.
Brand / code
Mektovi
Dosing & schedule
Route
Oral
Schedule
45 mg twice daily with encorafenib 450 mg once daily
Dose modifications
Hold for retinopathy, LVEF drop, CK rise
Monitoring
Ophthalmology at baseline and for symptoms; echocardiogram; CK

Source: www.accessdata.fda.gov/drugsatfda_docs/label/2023/210498s009lbl.pdf. Doses are for orientation; the current label governs.

Medicare
Part D (self-administered)

Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).

Commercial insurance
covered with prior authorisation

Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.

Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.

Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.

NICE recommendedNICE TA562 · 2019SMC: accepted
Appraised for
With encorafenib for BRAF V600 mutation-positive melanoma
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA562 · SMC advice: binimetinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 27 Jun 2018ApprovalUS

    Encorafenib + binimetinib approved for BRAF V600 melanoma

Approvals

RegionYearIndication
US2018BRAF V600E/K melanoma with encorafenib
US2023BRAF V600E metastatic NSCLC with encorafenib

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
87 studies13 recruiting79 Phase 28 Phase 3
Search “Binimetinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Binimetinib
intervention: Binimetinib
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend71 papers in the last 12 months+16% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Binimetinib" OR ABSTRACT:"Binimetinib" OR TITLE:"Mektovi" OR ABSTRACT:"Mektovi") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Binimetinib, not a curated reading list.

Connected

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