Treats unresectable or metastatic melanoma with BRAF V600E mutation. Sold as Tafinlar. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Dabrafenib Mesylate (sold as Tafinlar), first approved May 29, 2013, with 13 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Tafinlar | Part D | $255M | +47% | 3,309 |
| Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade GliomasBRAF V600 Mutation, Low-grade Glioma · University of California, San Francisco | Phase 2 | Recruiting | Aug 7, 2025 |
| Precision Cancer Therapy in Rare CancersRare Malignant Neoplasm · Oslo University Hospital | Phase 2 | Recruiting | Nov 7, 2023 |
| Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual TreatmentClinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma · National Cancer Institute (NCI) | Phase 1 / Phase 2 | Active, not recruiting | Sep 22, 2020 |
| Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H)Advanced Lymphoma, Advanced Malignant Solid Neoplasm · National Cancer Institute (NCI) | Phase 2 | Active, not recruiting | Jun 19, 2020 |
| A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF AberrationLow Grade Glioma (LGG) of Brain With BRAF Aberration, High Grade Glioma (HGG) of the Brain With BRAF Aberration · Pediatric Brain Tumor Consortium | Phase 1 / Phase 2 | Active, not recruiting | Dec 17, 2019 |
| Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade GliomaAnaplastic Astrocytoma, Anaplastic Astrocytoma, Not Otherwise Specified · National Cancer Institute (NCI) | Phase 2 | Active, not recruiting | Apr 18, 2019 |
| Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)Advanced Lymphoma, Advanced Malignant Solid Neoplasm · National Cancer Institute (NCI) | Phase 2 | Active, not recruiting | Jun 8, 2015 |
| Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 MelanomaClinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8 · National Cancer Institute (NCI) | Phase 3 | Active, not recruiting | Aug 25, 2014 |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Novartis