Dabrafenib - Novartis

Drug Profile

Dabrafenib - Novartis

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

Latest Information Update: 30 Jul 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; 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; Glioblastoma
  • Phase I/II Colorectal cancer; Solid tumours

Most Recent Events

  • 27 Jul 2018 Committee for Medicinal Products for Human Use (CHMP) of the EMA recommends approval of trametinib in combination with dabrafenib for Malignant melanoma (Adjuvant therapy, Combination therapy) in European Union
  • 02 Jul 2018 Launched for Malignant melanoma (Combination therapy, Adjuvant therapy) in Japan (PO)
  • 02 Jul 2018 Registered for Malignant melanoma (Combination therapy, Adjuvant therapy) in Japan (PO)
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