Dabrafenib

(Tafinlar®)

Dabrafenib

Drug updated on 4/24/2024

Dosage FormCapsule (oral; 50 mg, 75 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
  • Indicated for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
  • Indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
  • Indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.
  • Indicated for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
  • Indicated for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty and may be inaccurate or outdated, with no liability accepted for reliance on it. Learn more.

  • Dabrafenib (Tafinlar) shows promising anti-tumor efficacy in treating gliomas, particularly low-grade tumors. However, the high incidence of adverse events indicates considerable toxicity.
  • The utilization of dabrafenib for ameloblastoma patients with BRAF V600E mutations shows potential for tumor size reduction and restitutio ad integrum.
  • In comparison to other treatments for unresectable/metastatic BRAF V600-mutant melanoma, dabrafenib demonstrates superior safety and efficacy profiles over other treatment combinations like vemurafenib and cobimetinib.
  • For patients with melanoma brain metastases treated with dabrafenib after previous local treatment, improved disease control was observed compared to treatment-naive patients without significantly increased toxicity.
  • A network meta-analysis on metastatic melanoma found that dabrafenib plus trametinib was highly efficacious in terms of overall response rate (ORR) and had fewer serious adverse events compared to other combination therapies.
  • As an adjuvant therapy in resected melanoma, certain treatments had comparable or lower efficacy than a combination of dabrafenib plus trametinib, which demonstrated significant long-term benefits in recurrence-free survival beyond 12 months.
  • Dabrafenib combined with trametinib demonstrated favorable outcomes in both progression-free survival (PFS) and overall survival (OS), indicating its strong position as a first-line therapy for BRAF-mutated melanoma.
  • This information is derived from systematic reviews/meta-analyses based on documents provided about Tafinlar (dabrafenib).

Product Monograph / Prescribing Information

Document TitleYearSource
Tafinlar (dabrafenib) Prescribing Information.2023Novartis Pharmaceuticals Corporation, East Hanover, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The safety and efficacy of dabrafenib and trametinib in patients with glioma: A systematic review and meta-analysis.2024European Journal of Clinical Pharmacology
BRAF inhibitors in BRAF V600E-mutated ameloblastoma: systematic review of rare cases in the literature.2023Medical Oncology
Acceptability of drugs in the treatment of unresectable/metastatic BRAF V600-mutant melanoma: a systematic review and network meta-analysis.2022Frontiers in Oncology
Impact of previous local treatment for brain metastases on response to molecular targeted therapy in BRAF-mutant melanoma brain metastasis: a systematic review and meta-analysis.2022Frontiers in Oncology
Comparative efficacy and safety of targeted therapies for BRAF-mutant unresectable or metastatic melanoma: Results from a systematic literature review and a network meta-analysis.2022Cancer Treatment Reviews
Comparative efficacy and safety of adjuvant nivolumab versus other treatments in adults with resected melanoma: a systematic literature review and network meta-analysis.2021BMC Cancer
Adjuvant therapy of high-risk (stages IIC-IV) malignant melanoma in the post interferon-alpha era: a systematic review and meta-analysis.2021Frontiers in Oncology
Efficacy and safety of dabrafenib-trametinib in the treatment of unresectable or metastatic melanoma with BRAF V600 mutation: a systematic review and network meta-analysis. 2020Dermatologic Therapy
Network meta-analysis of therapies for previously untreated advanced BRAF-mutated melanoma. 2019Cancer Treatment Reviews
A systematic literature review and network meta-analysis of effectiveness and safety outcomes in advanced melanoma. 2019European Journal of Cancer
Efficacy and adverse events in metastatic melanoma patients treated with combination BRAF plus MEK inhibitors versus BRAF inhibitors: a systematic review.2019Cancers

Clinical Practice Guidelines