Difference between revisions of "Trabectedin (Yondelis)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
* 10/23/2015: [https://pubmed.ncbi.nlm.nih.gov/28774898/ FDA approved] for the treatment of patients with unresectable or metastatic [[liposarcoma]] or [[leiomyosarcoma]] who have received a prior [[Regimen_classes#Anthracycline-based_regimen|anthracycline-containing regimen]]. ''(Based on ET743-SAR-3007)'' | * 10/23/2015: [https://pubmed.ncbi.nlm.nih.gov/28774898/ FDA approved] for the treatment of patients with unresectable or metastatic [[liposarcoma]] or [[leiomyosarcoma]] who have received a prior [[Regimen_classes#Anthracycline-based_regimen|anthracycline-containing regimen]]. ''(Based on ET743-SAR-3007)'' | ||
− | + | ==History of changes in EMA indication== | |
+ | *9/17/2007: Initial authorization | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' ET-743 | *'''Code name:''' ET-743 | ||
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[[Category:Soft tissue sarcoma medications]] | [[Category:Soft tissue sarcoma medications]] | ||
+ | [[Category:EMA approved in 2007]] | ||
[[Category:FDA approved in 2015]] | [[Category:FDA approved in 2015]] |
Revision as of 12:56, 2 January 2023
General information
Class/mechanism: Alkylator, binds to the minor groove of DNA, which distorts the DNA helix and its major groove. This binding interrupts normal cell function and interferes with the expression of several several transcription factors, DNA binding proteins, and DNA repair mechanisms, which interrupts cell cycle and leads to tumor death.[1][2][3]
Route: IV
Extravasation: vesicant
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
Patient drug information
- Trabectedin (Yondelis) package insert[1]
- Trabectedin (Yondelis) patient drug information from manufacturer[4]
- Trabectedin (Yondelis) patient drug information (Chemocare)[5]
- Trabectedin (Yondelis) patient drug information (UpToDate)[6]
History of changes in FDA indication
- 10/23/2015: FDA approved for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who have received a prior anthracycline-containing regimen. (Based on ET743-SAR-3007)
History of changes in EMA indication
- 9/17/2007: Initial authorization
Also known as
- Code name: ET-743
- Brand name: Yondelis
References
- ↑ 1.0 1.1 1.2 Trabectedin (Yondelis) package insert
- ↑ Trabectedin (Yondelis) package insert (locally hosted backup)
- ↑ Yondelis manufacturer's website
- ↑ Trabectedin (Yondelis) patient drug information from manufacturer
- ↑ Trabectedin (Yondelis) patient drug information (Chemocare)
- ↑ Trabectedin (Yondelis) patient drug information (UpToDate)