Difference between revisions of "Dabrafenib (Tafinlar)"
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==Diseases for which it is established ''(work in progress)''== | ==Diseases for which it is established ''(work in progress)''== | ||
| + | *[[Low-grade glioma, pediatric]] | ||
*[[Melanoma,_BRAF-mutated|BRAF-mutated melanoma]] | *[[Melanoma,_BRAF-mutated|BRAF-mutated melanoma]] | ||
*[[Non-small cell lung cancer, BRAF-mutated|BRAF-mutated NSCLC]] | *[[Non-small cell lung cancer, BRAF-mutated|BRAF-mutated NSCLC]] | ||
| Line 20: | Line 21: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | ===[[Melanoma]]=== | + | ===[[Low-grade glioma, pediatric]]=== |
| + | *3/16/2023: FDA approved for pediatric patients 1 year of age and older with [[Low-grade glioma, pediatric|low-grade glioma (LGG)]] with a [[Biomarkers#BRAF|BRAF]] [[Biomarkers#V600E|V600E mutation]] who require systemic therapy. ''(Based on CDRB436G2201)'' | ||
| + | |||
| + | ===[[Melanoma, BRAF-mutated]]=== | ||
*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. ''(Based on BREAK-3 and BREAK-MB)'' | *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. ''(Based on BREAK-3 and BREAK-MB)'' | ||
*1/10/2014: Accelerated approval 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. ''(Based on COMBI-d, COMBI-v, and COMBI-MB)'' | *1/10/2014: Accelerated approval 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. ''(Based on COMBI-d, COMBI-v, and COMBI-MB)'' | ||
*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. ''(Based on COMBI-AD)'' | *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. ''(Based on COMBI-AD)'' | ||
| − | ===[[Non-small cell lung cancer]]=== | + | ===[[Non-small cell lung cancer, BRAF-mutated]]=== |
*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. ''(Based on BRF113928 previously treated & BRF113928 untreated)'' | *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. ''(Based on BRF113928 previously treated & BRF113928 untreated)'' | ||
| − | ===[[Thyroid cancer]]=== | + | ===[[Thyroid cancer, BRAF-mutated]]=== |
*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. ''(Based on ROAR)'' | *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. ''(Based on ROAR)'' | ||
| Line 51: | Line 55: | ||
[[Category:BRAF medications]] | [[Category:BRAF medications]] | ||
[[Category:Colorectal cancer medications]] | [[Category:Colorectal cancer medications]] | ||
| + | [[Category:Low-grade glioma, pediatric medications]] | ||
[[Category:Melanoma medications]] | [[Category:Melanoma medications]] | ||
[[Category:Non-small cell lung cancer medications]] | [[Category:Non-small cell lung cancer medications]] | ||
Revision as of 22:15, 16 March 2023
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 established (work in progress)
- Low-grade glioma, pediatric
- BRAF-mutated melanoma
- BRAF-mutated NSCLC
- BRAF-mutated anaplastic thyroid cancer
Diseases for which it is used
Patient drug information
- Dabrafenib (Tafinlar) package insert[1]
- Dabrafenib (Tafinlar) patient drug information (Chemocare)[4]
History of changes in FDA indication
Low-grade glioma, pediatric
- 3/16/2023: FDA approved for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. (Based on CDRB436G2201)
Melanoma, BRAF-mutated
- 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. (Based on BREAK-3 and BREAK-MB)
- 1/10/2014: Accelerated approval 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. (Based on COMBI-d, COMBI-v, and COMBI-MB)
- 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. (Based on COMBI-AD)
Non-small cell lung cancer, BRAF-mutated
- 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. (Based on BRF113928 previously treated & BRF113928 untreated)
Thyroid cancer, BRAF-mutated
- 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. (Based on ROAR)
History of changes in EMA indication
- 8/26/2013: Initial marketing authorization as Tafinlar.
Also known as
- Code names: GSK2118436, GSK-2118436A
- Generic name: dabrafenib mesylate
- Brand name: Rafinlar, Tafinlar