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Binimetinib - Array BioPharma/Ono Pharmaceutical/Pierre Fabre

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: 20 Mar 2024

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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

Highest Development Phases

  • Marketed Colorectal cancer; Malignant melanoma
  • Preregistration Non-small cell lung cancer; 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

Most Recent Events

  • 08 Mar 2024 Pierre Fabre completes a Phase-III clinical trials in Malignant melanoma (Adjuvant therapy, Combination therapy) in Italy (PO) (EudraCT2021-000743-41)
  • 02 Nov 2023 Preregistration for Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater, First-line therapy) in European Union (PO)
  • 02 Nov 2023 European Medicines Agency validates MAA for encorafenib in Non-small cell lung cancer
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