Dabrafenib
- Generic Name
- Dabrafenib
- Brand Names
- Tafinlar, Finlee
- Drug Type
- Small Molecule
- Chemical Formula
- C23H20F3N5O2S2
- CAS Number
- 1195765-45-7
- Unique Ingredient Identifier
- QGP4HA4G1B
- 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
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain
- First Posted Date
- 2010-12-24
- Last Posted Date
- 2014-05-08
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 172
- Registration Number
- NCT01266967
- Locations
- 🇮🇹
GSK Investigational Site, Padova, Veneto, Italy
An Absorption, Distribution, Metabolism and Excretion (ADME) Study of Single Oral Dose [14C] GSK2118436 in Subjects With BRAF Mutant Solid Tumors
- First Posted Date
- 2010-12-20
- Last Posted Date
- 2017-11-13
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 4
- Registration Number
- NCT01262963
- Locations
- 🇺🇸
GSK Investigational Site, Tacoma, Washington, United States
A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors
- Conditions
- Cancer
- Interventions
- First Posted Date
- 2010-11-01
- Last Posted Date
- 2019-03-22
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 214
- Registration Number
- NCT01231594
- Locations
- 🇬🇧
Novartis Investigative Site, London, United Kingdom
A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
- First Posted Date
- 2010-10-25
- Last Posted Date
- 2017-10-04
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 251
- Registration Number
- NCT01227889
- Locations
- 🇪🇸
GSK Investigational Site, Sevilla, Spain
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma
- First Posted Date
- 2010-06-30
- Last Posted Date
- 2017-09-27
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 92
- Registration Number
- NCT01153763
- Locations
- 🇮🇹
GSK Investigational Site, Padova, Veneto, Italy
Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212
- First Posted Date
- 2010-02-19
- Last Posted Date
- 2019-07-05
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 430
- Registration Number
- NCT01072175
- Locations
- 🇦🇺
Novartis Investigative Site, Heidelberg, Victoria, Australia
A Phase I Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2118436 in Subjects With Solid Tumors
- First Posted Date
- 2009-04-13
- Last Posted Date
- 2017-11-13
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 170
- Registration Number
- NCT00880321
- Locations
- 🇦🇺
GSK Investigational Site, Nedlands, Western Australia, Australia
Drug Development Updates
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