Binimetinib - Array BioPharma/Pierre Fabre

Drug Profile

Binimetinib - Array BioPharma/Pierre Fabre

Alternative Names: ARRY-162; ARRY-438162; MEK-162; ONO-7703

Latest Information Update: 15 Sep 2017

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At a glance

  • Originator Array BioPharma; Dana-Farber Cancer Institute
  • Developer Array BioPharma; Dana-Farber Cancer Institute; German Cancer Research Center; Memorial Sloan-Kettering Cancer Center; Merck KGaA; Novartis; Pierre Fabre; Plexxikon; Seoul National University Hospital; University of Heidelberg; University of Pittsburgh
  • Class Amides; Anti-inflammatories; Antineoplastics; Benzimidazoles; Fluorine compounds; 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Malignant melanoma
  • Phase III Colorectal cancer; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Phase II Haematological malignancies; Multiple myeloma; Neurofibromatoses; Non-small cell lung cancer; Solid tumours
  • Phase I/II Acute myeloid leukaemia; Biliary cancer; Chronic myeloid leukaemia; Gastrointestinal stromal tumours; Pancreatic cancer
  • Discontinued Rheumatoid arthritis; Uveal melanoma

Most Recent Events

  • 14 Sep 2017 Planned Prescription Drug User Fee Act (PDUFA) date for Malignant melanoma (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in USA (PO) is 2018-06-30
  • 12 Sep 2017 US FDA accepts NDA for binimetinib for Malignant melanoma (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) for review
  • 09 Sep 2017 Interim efficacy and adverse events data from a phase III trial in Malignant melanoma released by Array BioPharma and Pierre Fabre
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