Drug Profile

Binimetinib - Array BioPharma/Ono Pharmaceutical/Pierre Fabre

Alternative Names: ARRY-162; ARRY-438162; Balimek; MEK-162; MEKTOVI; ONO-7703; PF-06811462

Latest Information Update: 28 Feb 2026

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At a glance

Originator Array BioPharma
Developer Array BioPharma; Childrens Hospital Los Angeles; Dana-Farber Cancer Institute; German Cancer Research Center; Mayo Clinic; Memorial Sloan-Kettering Cancer Center; Merck KGaA; National Cancer Institute (USA); Novartis; Ono Pharmaceutical; Pfizer; Pierre Fabre; Seoul National University Hospital; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Swiss Group for Clinical Cancer Research; University Health Network; University of Heidelberg; University of Pittsburgh
Class Amides; Anti-inflammatories; Antineoplastics; Benzimidazoles; Fluorine compounds; Halogenated hydrocarbons; Small molecules
Mechanism of Action MAP kinase kinase 1 inhibitors; MAP kinase kinase 2 inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Ovarian cancer; Malignant melanoma
New Molecular Entity Yes

Marketed Colorectal cancer; Malignant melanoma; Non-small cell lung cancer
Preregistration Thyroid cancer
Phase III Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
Phase II Brain metastases; Glioma; Haematological malignancies; Multiple myeloma; Neurofibromatosis 1; Solid tumours
Phase I/II Acute myeloid leukaemia; Biliary cancer; Cancer; Chronic myeloid leukaemia; Gastrointestinal stromal tumours; Pancreatic cancer; Triple negative breast cancer
No development reported Uveal melanoma
Discontinued Rheumatoid arthritis

28 Feb 2026 No recent reports of development identified for phase-I development in Non-small-cell-lung-cancer(Combination therapy, Late-stage disease, Second-line therapy or greater) in USA (PO)
02 Feb 2026 Pfizer and Merck Sharp & Dohme terminates the phase II PORTSIDE trial in Malignant melanoma (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in Poland, Spain, Germany, Italy, Slovakia (PO), due to inability to recruit the target number of patients, while there were no safety and/or efficacy concerns involved in the decision to stop enrolment (CTIS2023-509471-17-00) (NCT05926960)
31 Dec 2025 Dana-Farber Cancer Institute completes a phase I trial in Non-small cell lung cancer (Combination therapy, Late-stage disease, Second-line therapy or greater) in USA (PO) (NCT03170206)

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