Overview
Dabrafenib mesylate (Tafinlar) is a reversible ATP-competitive kinase inhibitor and targets the MAPK pathway. It was approved on May 29, 2013, for the treatment of melanoma with V600E or V6000K mutation. It was also used for metastatic non-small cell lung cancer with the same mutation. In May 2018, Tafinlar (dabrafenib), in combination with Mekinist (Trametinib), was approved to treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene.
Background
Dabrafenib mesylate (Tafinlar) is a reversible ATP-competitive kinase inhibitor and targets the MAPK pathway. It was approved on May 29, 2013, for the treatment of melanoma with V600E or V6000K mutation. It was also used for metastatic non-small cell lung cancer with the same mutation. In May 2018, Tafinlar (dabrafenib), in combination with Mekinist (Trametinib), was approved to treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene.
Indication
As monotherapy, dabrafenib is indicated to treat unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. In combination with trametinib, dabrafenib is indicated to treat for: Dabrafenib has limitations of use: it is neither indicated for treating patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition nor wild-type BRAF solid tumours.
Associated Conditions
- Locally Advanced Anaplastic Thyroid Cancer
- Low-Grade Glioma
- Melanoma
- Metastatic Anaplastic Thyroid Cancer
- Metastatic Melanoma
- Metastatic Non-Small Cell Lung Cancer
- Metastatic Solid Tumours
- Unresectable Melanoma
- Unresectable Solid Tumor
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/08 | Phase 4 | Not yet recruiting | Fujian Medical University | ||
2025/02/11 | Phase 2 | Not yet recruiting | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | ||
2024/12/18 | Phase 2 | Recruiting | Tianjin Medical University Second Hospital | ||
2024/10/22 | Phase 2 | Recruiting | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | ||
2024/08/01 | N/A | Recruiting | |||
2024/07/01 | Phase 2 | Recruiting | |||
2024/06/26 | Phase 3 | Recruiting | ECOG-ACRIN Cancer Research Group | ||
2024/04/12 | Phase 2 | Recruiting | Saint Petersburg State University, Russia | ||
2024/02/20 | Phase 3 | Not yet recruiting | Shandong University | ||
2024/01/08 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novartis Pharmaceuticals Corporation | 0078-0681 | ORAL | 75 mg in 1 1 | 3/16/2023 | |
| Novartis Pharmaceuticals Corporation | 0078-0682 | ORAL | 50 mg in 1 1 | 3/16/2023 | |
| Novartis Pharmaceuticals Corporation | 0078-1154 | ORAL | 10 mg in 1 1 | 3/16/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/15/2023 | ||
Authorised | 11/15/2023 | ||
Authorised | 11/15/2023 | ||
Authorised | 11/15/2023 | ||
Authorised | 8/26/2013 | ||
Authorised | 8/26/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TAFINLAR HARD CAPSULE 50MG | SIN14830P | CAPSULE | 50mg | 8/24/2015 | |
| TAFINLAR HARD CAPSULE 75MG | SIN14831P | CAPSULE | 75mg | 8/24/2015 | |
| TAFINLAR DISPERSIBLE TABLET 10MG | SIN17019P | TABLET, FOR SUSPENSION | 10mg | 6/3/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Dabrafenib mesylate capsules | H20190066 | 化学药品 | 胶囊剂 | 12/18/2019 | |
| Dabrafenib mesylate capsules | 国药准字HJ20190066 | 化学药品 | 胶囊剂 | 9/10/2024 | |
| Dabrafenib mesylate capsules | 国药准字HJ20190067 | 化学药品 | 胶囊剂 | 9/10/2024 | |
| Dabrafenib mesylate capsules | H20190067 | 化学药品 | 胶囊剂 | 12/18/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TAFINLAR dabrafenib (as mesilate) 50 mg capsule bottle | 200922 | Medicine | A | 8/27/2013 | |
| TAFINLAR dabrafenib (as mesilate) 10 mg dispersible tablet bottle | 397093 | Medicine | A | 12/6/2023 | |
| TAFINLAR dabrafenib (as mesilate) 75 mg capsule bottle | 200936 | Medicine | A | 8/27/2013 |