Dabrafenib - Novartis

Drug Profile

Dabrafenib - Novartis

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

Latest Information Update: 09 Nov 2018

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At a glance

  • Originator GlaxoSmithKline
  • Developer Dana-Farber Cancer Institute; GlaxoSmithKline; National Cancer Institute (USA); 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; Thyroid cancer
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 01 Nov 2018 Registered for Malignant melanoma (Combination therapy, Adjuvant therapy) in Canada (PO)
  • 22 Oct 2018 Updated efficacy data from a phase III COMBI-AD trial in Melanoma released by Novartis
  • 15 Oct 2018 Phase-II clinical trials in Colorectal cancer (Combination therapy, Metastatic disease, Second-line therapy or greater) in USA (PO) (NCT03668431)
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