Dabrafenib - Novartis

Drug Profile

Dabrafenib - Novartis

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

Latest Information Update: 28 Dec 2017

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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
  • Phase I/II Colorectal cancer; Solid tumours

Most Recent Events

  • 22 Dec 2017 Preregistration for Malignant melanoma (Combination therapy, Adjuvant therapy) in USA (PO)
  • 22 Dec 2017 Dabrafenib receives priority review status for Malignant melanoma (Combination therapy, Adjuvant therapy) in USA (PO)
  • 08 Nov 2017 Phase-II clinical trials in Malignant melanoma (Neoadjuvant therapy, Combination therapy, Late-stage disease, Metastatic disease) in Australia (PO) (NCT02858921)
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