Dabrafenib - Novartis

Drug Profile

Dabrafenib - Novartis

Alternative Names: 2118436; DRB 436; GSK 2118436A; GSK-2118436; Tafinlar

Latest Information Update: 07 Mar 2018

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At a glance

  • Originator GlaxoSmithKline
  • Developer GlaxoSmithKline; Novartis; University of Texas M. D. Anderson Cancer Center
  • Class Antineoplastics; Fluorobenzenes; Pyrimidines; Small molecules; Sulfonamides; Thiazoles
  • Mechanism of Action Protein kinase inhibitors; 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.

    Yes - Malignant melanoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Malignant melanoma
  • Registered Non-small cell lung cancer
  • Phase II Brain metastases; Cancer; Glioblastoma
  • Phase I/II Colorectal cancer; Solid tumours

Most Recent Events

  • 07 Mar 2018 Novartis in collaboration with Dana-Farber Cancer Institute plans a phase I/II trial for Malignant melanoma (Combination therapy, Second-line therapy or greater, Late-stage disease) in USA in March 2018 (NCT03455764)
  • 14 Feb 2018 Novartis completes a phase II trial for Brain metastases of malignant melanoma (Combination therapy, Metastatic disease) in USA, Australia, Canada, Spain, Italy, Germany and France (PO) (NCT02039947)
  • 28 Dec 2017 Phase-II clinical trials in Glioblastoma (In children, In adolescents, Second-line therapy or greater, Combination therapy) in Sweden, Germany, USA (PO) (NCT02684058) (EudraCT2015-004015-20)
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