Dabrafenib

Drug Profile

Dabrafenib

Alternative Names: 2118436; B-RafV600E inhibitor; DRB 436; GSK 2118436A; GSK-2118436; Tafinlar

Latest Information Update: 14 Feb 2017

Price : $50

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 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 25 Jan 2017 GlaxoSmithKline withdraws a phase I trial prior to enrolment due to change in strategy for Malignant melanoma (Late-stage disease, Metastatic disease, Monotherapy, Combination therapy) in China (NCT02447939)
  • 01 Dec 2016 Novartis Pharmaceuticals initiates enrolment in a phase I pharmacokinetics trial (In volunteers) in USA (PO) (NCT02852239)
  • 01 Dec 2016 Novartis Pharmaceuticals initiates enrolment in a phase I pharmacokinetics trial (In volunteers) in USA (PO) (NCT02873650)
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