| Pharmaceutical Information |
| Drug Name |
Dabrafenib |
| Drug ID |
BADD_D00566 |
| Description |
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 [L2718].
In May 2018, Tafinlar (dabrafenib) and Mekinist ([DB08911]) in combination have been approved to treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene [L2714]. |
| Indications and Usage |
Tafinlar is a kinase inhibitor that was initially indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test [FDA label].
Tafinlar in combination with [DB08911] is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. The use in combination is based on the demonstration of durable response rate. Improvement in disease-related symptoms or overall survival has not been demonstrated for Tafinlar in combination with trametinib [FDA label].
In May 2018, Tafinlar (dabrafenib) and Mekinist ([DB08911]) have been approved in combination to treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene [L2712]. |
| Marketing Status |
approved; investigational |
| ATC Code |
L01EC02 |
| DrugBank ID |
DB08912
|
| KEGG ID |
D10064
|
| MeSH ID |
C561627
|
| PubChem ID |
44462760
|
| TTD Drug ID |
D05ROI
|
| NDC Product Code |
0078-0681; 0078-0682; 0078-1154; 52482-007 |
| UNII |
QGP4HA4G1B
|
| Synonyms |
dabrafenib | GSK 2118436 | GSK2118436 | GSK-2118436 |
|
| Chemical Information |
| Molecular Formula |
C23H20F3N5O2S2 |
| CAS Registry Number |
1195765-45-7 |
| SMILES |
CC(C)(C)C1=NC(=C(S1)C2=NC(=NC=C2)N)C3=C(C(=CC=C3)NS(=O)(=O)C4=C(C=CC=C4F)F)F |
| Chemical Structure |
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| ADRs Induced by Drug |
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