Difference between revisions of "Trabectedin (Yondelis)"
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==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2007-09-17: Initial authorization | *2007-09-17: Initial authorization | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2015-09-28: Initial approval for the treatment of patients with [[soft tissue sarcoma]]. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' ET-743 | *'''Code name:''' ET-743 | ||
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[[Category:EMA approved in 2007]] | [[Category:EMA approved in 2007]] | ||
[[Category:FDA approved in 2015]] | [[Category:FDA approved in 2015]] | ||
| + | [[Category:PMDA approved in 2015]] | ||
Revision as of 19:45, 9 June 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
- 2015-10-23: 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
- 2007-09-17: Initial authorization
History of changes in PMDA indication
- 2015-09-28: Initial approval for the treatment of patients with soft tissue sarcoma.
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)