Difference between revisions of "Dabrafenib (Tafinlar)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *5/29/2013: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm354199.htm FDA approved] | + | ===[[Melanoma]]=== |
| − | *1/10/2014: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm381159.htm FDA approved] to be used together with [[Trametinib (Mekinist)]] | + | *5/29/2013: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm354199.htm FDA approved] for the treatment of patients with unresectable or metastatic [[melanoma]] with [[Biomarkers#BRAF|BRAF]] [[Biomarkers#V600E|V600E mutation]] as detected by an FDA-approved test.<ref name="insert"></ref> |
| − | *6/22/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm564331.htm FDA approved] in combination with [[Trametinib (Mekinist)]] "for patients with metastatic [[Non-small_cell_lung_cancer | + | *1/10/2014: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm381159.htm FDA approved] to be used together with [[Trametinib (Mekinist)]] for the treatment of patients with unresectable or metastatic [[melanoma]] with [[Biomarkers#BRAF|BRAF]] [[Biomarkers#V600E|V600E]] or [[Biomarkers#V600K|V600K mutations]] as detected by an FDA-approved test. |
| − | + | *4/30/2018: Regular FDA approval with [[Trametinib (Mekinist)]] "in combination for the adjuvant treatment of patients with [[melanoma]] with [[Biomarkers#BRAF|BRAF]] [[Biomarkers#V600E|V600E]] or [[Biomarkers#V600K|V600K mutations]], as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. | |
| − | *5/4/2018: FDA approval with [[Trametinib (Mekinist)]] | + | |
| + | ===[[Non-small cell lung cancer]]=== | ||
| + | *6/22/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm564331.htm FDA approved] in combination with [[Trametinib (Mekinist)]] "for patients with metastatic [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] with [[Biomarkers#BRAF|BRAF]] [[Biomarkers#V600E|V600E mutation]] as detected by an FDA-approved test." | ||
| + | |||
| + | ===[[Thyroid cancer]]=== | ||
| + | *5/4/2018: FDA approval with [[Trametinib (Mekinist)]] in combination for the treatment of patients with locally advanced or metastatic [[Thyroid_cancer|anaplastic thyroid cancer (ATC)]] with [[Biomarkers#BRAF|BRAF]] [[Biomarkers#V600E|V600E mutation]] and with no satisfactory locoregional treatment options. | ||
==Also known as== | ==Also known as== | ||
Revision as of 17:04, 10 January 2020
General information
Class/mechanism: BRAF kinase inhibitor. Dabrafenib inhibits some mutated BRAF kinases, such as BRAF V600E, BRAF V600K, and BRAF V600D. Some BRAF mutations such as BRAF V600E cause constitutive activation of the BRAF pathway, which drives tumor cell growth.[1][2][3]
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp,UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
- BRAF-mutated melanoma
- BRAF-mutated NSCLC
- BRAF-mutated anaplastic thyroid cancer
- BRAF-mutated tumors (disease-agnostic)
Patient drug information
History of changes in FDA indication
Melanoma
- 5/29/2013: FDA approved for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.[1]
- 1/10/2014: FDA approved to be used together with Trametinib (Mekinist) for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
- 4/30/2018: Regular FDA approval with Trametinib (Mekinist) "in combination 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.
Non-small cell lung cancer
- 6/22/2017: FDA approved in combination with Trametinib (Mekinist) "for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test."
Thyroid cancer
- 5/4/2018: FDA approval with Trametinib (Mekinist) in combination 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.
Also known as
- Code names: GSK2118436, GSK-2118436A
- Generic name: dabrafenib mesylate
- Brand name: Tafinlar