Drug updated on 7/25/2024
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.
Latest News
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Summary
- 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 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 |