Drug updated on 9/4/2024
| 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
Summary
- Tafinlar (dabrafenib) is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, following complete resection with lymph node involvement, and for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation. It is also indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation when no satisfactory locoregional treatment options are available. Additionally, it is indicated for adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors or low-grade glioma (LGG) with BRAF V600E mutation who require systemic therapy or have progressed following prior treatment.
- This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
- Low-Grade Gliomas (LGG): Dabrafenib demonstrated an Overall Response Rate (ORR) of 50% (95% CI: 35-65%), with 6-month Progression-Free Survival (PFS) of 87% and 12-month PFS of 67%.
- High-Grade Gliomas (HGG): The ORR was 40% (95% CI: 29-51%), with a Complete Response (CR) Rate of 13% (95% CI: 05-27%). The 6-month PFS was 67%, and the 12-month PFS was 44%.
- Melanoma Brain Metastases (BMs): In patients with previously treated BMs, intracranial disease control was higher compared to treatment-naïve patients (OR 0.58 [95% CI: 0.34, 0.97], p = 0.04). There was a trend toward improved PFS in the previously treated cohort (HR 1.22 [95% CI: 0.98, 1.52], p = 0.08), with significant improvement in PFS for those receiving the BRAF/MEK inhibitor combination (HR 1.67 [95% CI: 1.06, 2.62], p = 0.03).
- Ameloblastoma: Dabrafenib showed effectiveness in reducing tumor size, with some cases achieving complete resolution (restitutio ad integrum).
- Gliomas: Grade 1-4 adverse events occurred in 100% of low-grade glioma (LGG) patients and 63% of high-grade glioma (HGG) patients.
- Melanoma: Dabrafenib combined with trametinib demonstrated a superior safety profile with fewer any-grade adverse events compared to vemurafenib and cobimetinib; no significant difference in overall, grade 3/4, or severe adverse events between treatment-naïve and previously treated melanoma brain metastases cohorts.
- Adjuvant Therapy for Resected Melanoma: Nivolumab/ipilimumab and ipilimumab monotherapy were associated with higher toxicity, whereas BRAF/MEK inhibitors showed a favorable safety profile compared to immune checkpoint inhibitors.
- There is no population type or subgroup information available in the reviewed studies.
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 |