Drug Profile


Alternative Names: LGX-818; NVP-LGX818; NVP-LGX818-NXA; ONO-7702

Latest Information Update: 14 Nov 2017

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At a glance

  • Originator Novartis Pharmaceuticals Corporation
  • Developer Array BioPharma; German Cancer Research Center; Merck KGaA; Novartis Pharmaceuticals Corporation; University of Heidelberg
  • Class Antineoplastics; Carbamates; Pyrazoles; Pyrimidines; Small molecules; Sulfonamides
  • Mechanism of Action Proto oncogene protein b raf inhibitors
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Malignant melanoma
  • Phase III Colorectal cancer
  • Phase II Multiple myeloma; Solid tumours

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 encorafenib 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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