Dabrafenib

(Tafinlar®)

Tafinlar®

Drug updated on 7/25/2024

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

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Summary
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  • Dabrafenib (Tafinlar) is indicated for the treatment of patients with unresectable or metastatic melanoma, adjuvant treatment post-resection in melanoma, metastatic non-small cell lung cancer (NSCLC), locally advanced or metastatic anaplastic thyroid cancer (ATC), and pediatric low-grade glioma (LGG) with BRAF V600E mutations.
  • A total of 11 systematic reviews and meta-analyses were reviewed to gather information on dabrafenib's efficacy and safety across various indications.
  • In treating low-grade gliomas (LGG), dabrafenib combined with trametinib showed a 50% overall response rate and high six-month progression-free survival rates but had significant toxicity reported in all LGG patients studied.
  • For ameloblastoma, both dabrafenib and vemurafenib demonstrated tumor size reductions; some cases achieved complete remission. The age range was broad from 10 to 86 years old, showing mixed results based on initial diagnoses versus recurrent/metastatic cases.
  • In metastatic melanoma settings, combination therapy of dabrafenib/trametinib outperformed other therapies like vemurafenib/cobimetinib regarding overall response rates and lower adverse event risks while providing superior progression-free survival compared to monotherapies or immunotherapies such as ipilimumab/nivolumab.
  • Patients treated for melanoma brain metastases who had prior brain treatments experienced better intracranial disease control when using BRAF inhibitors combined with MEK inhibitors. Adverse events were similar between different patient cohorts within this group.
  • Comparison studies revealed that targeted therapy combinations like dabrafenib/trametinib often provided more effective outcomes than monotherapy or immunotherapy options. However, encorafenib/binimetinib sometimes showed superior efficacy over the former combination in certain comparisons involving advanced/metastatic melanomas with BRAF mutations.

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