Drug updated on 4/24/2024
| Dosage Form | Capsule (oral; 50 mg, 75 mg) |
| Drug Class | Kinase 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.
Summary
- 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 Title | Year | Source |
|---|---|---|
| Tafinlar (dabrafenib) Prescribing Information. | 2023 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| European consensus-based interdisciplinary guideline for melanoma. part 2: treatment - update 2022. | 2022 | European Journal of Cancer |
| Systemic therapy for melanoma: ASCO guideline. | 2020 | Journal of Clinical Oncology |
| Systemic adjuvant therapy for adult patients at high risk for recurrent cutaneous or mucosal melanoma: an Ontario Health (Cancer Care Ontario) clinical practice guideline. | 2020 | Current Oncology |
| European consensus-based interdisciplinary guideline for melanoma. Part 2: diagnostics – update 2019. | 2019 | European Journal of Cancer |