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: 25 Sep 2025

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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

30 May 2025 Efficacy and adverse event data from a phase III trial in Malignant melanoma presented at the 61st Annual Meeting of the American Society of Clinical Oncology 2025 (ASCO-2025)
30 May 2025 Updated efficacy data from a phase I/II trial in Gastrointestinal stromal tumor were presented at the 61st Annual Meeting of the American Society of Clinical Oncology (ASCO-2025)
03 Jan 2025 Updated efficacy and adverse event data from the phase III PHAROS trial in Non-small cell lung cancer presented at the 49th European Society for Medical Oncology Congress (ESMO-2024)

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