Drug · Small Molecule

Binimetinib

CI-DRUG-00000110Explore in graph →NCIt C84865 CHEMBL3187723 CIViC Approved

Regulatory

Approvals (8)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory8 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as MEKTOVI (DIN 02513080) under ATC L01EE03 BINIMETINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 5, 2021	health-canada-dpd
EU EMA	—	MelanomaBinimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.Non-small cell lung cancer (NSCLC)Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.	approved	Sep 20, 2018	ema
US FDA	—	Efficacy supplement 2025-03-12 (see label)	approved	Mar 12, 2025	openfda
US FDA

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	30	12	5	98	8	CA, EU, US	Jun 27, 2018	Mar 24, 2011
Malignant Lung Neoplasm	Approved	Phase 2	4	0	0	17	1	US	Jun 27, 2018	Dec 30, 2013
Cutaneous Melanoma	Phase2	Phase 2	4	2	0	6	0	—	—	Dec 9, 2016
Malignant Breast Neoplasm	Phase2	Phase 2	4	2	0	6	0	—

Curated evidence

Clinical evidence (24)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–24 of 24 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
RAF1 Fusion1
Binimetinib	Acral Lentiginous Melanoma

Clinical trials

Trials with this intervention (100)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 100 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT05564377	Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial	recruiting	Phase 2	2,900	National Cancer Institute (NCI)NIH	2	Sep 28, 2026	clinicaltrials
NCT04322383	Binimetinib for People With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant	recruiting

Molecule

Record

Kind: Small Molecule
Mechanism: Dual specificity mitogen-activated protein kinase kinase 1 inhibitor; Dual specificity mitogen-activated protein kinase kinase 2 inhibitor
Targets: 2 genes
UNII: 181R97MR71
Aliases: ARRY 162, ARRY-162, ARRY162, ARRY 438162, ARRY438162, Binimetinib, MEK 162, MEK-162, MEK162, Mektovi, MEKTOVI, NVP-MEK162

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (4)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EE03	BINIMETINIB
DIN (Health Canada)	02513080	MEKTOVI
DPD drug code

BRAF V600K2
Binimetinib + EncorafenibCombination	Cutaneous MelanomaALIAS	Predictive	B	Supports Sensitivity Response	4	submitted	EID13183 In the randomized phase III COLUMBUS trial of patients with locally advanced unresectable or metastatic BRAF V600-mutant melanoma, 22 patients with BRAF V600K received encorafenib plus binimetinib and… (full text at CIViC) PMID 29573941 · Dummer et al., 2018 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID13185 In the 5-year update of the randomized phase III COLUMBUS trial of patients with locally advanced unresectable or metastatic BRAF V600-mutant melanoma, 22 patients with BRAF V600K received encorafenib… (full text at CIViC) PMID 35862871 · Dummer et al., 2022 · Open in CIViC	civic

BRAF V600K2

Binimetinib + EncorafenibCombination

Cutaneous MelanomaALIAS

Predictive

Supports Sensitivity Response

submitted

EID13183

In the randomized phase III COLUMBUS trial of patients with locally advanced unresectable or metastatic BRAF V600-mutant melanoma, 22 patients with BRAF V600K received encorafenib plus binimetinib and… (full text at CIViC)

PMID 29573941 · Dummer et al., 2018 · Open in CIViC

BRAF V600E2
Binimetinib + Cetuximab + EncorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID7260 In a phase III trial, patients with BRAF V600E mutated metastatic colorectal cancer received triplet combination with encorafenib + binimetinib + cetuximab in a second or third-line setting. In the sa… (full text at CIViC) Open in CIViC	civic
Binimetinib + Cetuximab + EncorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	5	accepted	EID7612 665 patients with BRAF V600E-mutated metastatic CRC were enrolled In this open-label, phase 3 trial. Patients were randomly assigned in a 1:1:1 ratio to receive encorafenib, binimetinib, and cetuximab… (full text at CIViC) PMID 31566309 · Kopetz et al., 2019 · Open in CIViC	civic

KRAS Mutation2
Binimetinib + PalbociclibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	accepted	EID4869 A preclinical study to investigate the efficacy of Binimetinib, Palbociclib and the combination on KRAS mutant colorectal cancer cell lines, cell line-derived and patient-derived xenografts. The com… (full text at CIViC) PMID 27167191 · Lee et al., 2016 · Open in CIViC	civic
Binimetinib	Malignant Ovarian Serous TumorALIAS	Predictive	B	Supports Sensitivity Response	3	accepted	EID8773 Post hoc analysis of a randomized phase 3 trial (MILO/ENGOT-ov11) suggests a possible association between KRAS mutation and response to binimetinib in patients with pretreated (1-3 lines of prior chem… (full text at CIViC) PMID 32822286 · Monk et al., 2020 · Open in CIViC	civic