Dabrafenib

(Tafinlar®)

Dabrafenib

Drug updated on 11/10/2023

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

Indication

  • For the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
  • 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.
  • For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
  • 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.
  • 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.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
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
Initial clinical guidance report: dabrafenib (Tafinlar) in combination with trametinib (Mekinist).2021CADTH
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
Economic evaluation of systemic treatments for advanced melanoma: a systematic review.2020Value in Health
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
Final clinical guidance report: dabrafenib and trametinib (Tafinlar and Mekinist) for melanoma adjuvant therapy. 2019CADTH
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