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Dabrafenib - Novartis

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Drug Profile

Dabrafenib - Novartis

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

Latest Information Update: 25 Apr 2026

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At a glance

  • Originator GlaxoSmithKline
  • Developer BeOne Medicines; 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 Glioma; Malignant melanoma; Non-small cell lung cancer; Solid tumours; Thyroid cancer
  • Registered Acral lentiginous melanoma
  • Phase II Brain metastases; Cancer; Colorectal cancer

Most Recent Events

  • 26 Mar 2026 Preregistration for Malignant melanoma (Adjuvant therapy, In adolescents, In adults, In the elderly, Late-stage disease) in European Union (PO) prior to March 2026
  • 26 Mar 2026 Preregistration for Malignant melanoma (Combination therapy, In adolescents, Inoperable/Unresectable, Metastatic disease, In adults, In the elderly) in European Union (PO) prior to March 2026
  • 26 Mar 2026 Preregistration for Malignant melanoma (Monotherapy, Inoperable/Unresectable, In adolescents, In adults, In the elderly, Metastatic disease) in European Union (PO) prior to March 2026

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