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Dabrafenib - Novartis

Drug Profile

Dabrafenib - Novartis

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

Latest Information Update: 07 Dec 2023

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At a glance

  • Originator GlaxoSmithKline
  • Developer BeiGene; Dana-Farber Cancer Institute; GSK; 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; Non-small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Malignant melanoma; Non-small cell lung cancer
  • Registered Acral lentiginous melanoma; Glioma; Solid tumours; Thyroid cancer
  • Phase II Brain metastases; Cancer; Colorectal cancer

Most Recent Events

  • 06 Dec 2023 Novartis settles patent infringement lawsuit filed by Plexxikon for sale of dabrafenib in USA
  • 28 Aug 2023 No recent reports of development identified for phase-I development in Colorectal-cancer(Combination therapy, Late-stage disease, Metastatic disease) in Germany (PO, Capsule)
  • 31 Jul 2023 Novartis completes the phase III COMBI-AD trial in Malignant melanoma (Combination therapy, Adjuvant therapy) in USA, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Japan, New Zealand, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, Taiwan and United Kingdom (PO, Capsule, bid) (NCT01682083) (EudraCT2012-001266-15)
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