Trabectedin (Yondelis)

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.
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.

Diseases for which it is used

• Leiomyosarcoma
• Liposarcoma
• Ovarian cancer
• Soft tissue sarcoma

Patient drug information

• Trabectedin (Yondelis) package insert
• Trabectedin (Yondelis) patient drug information from manufacturer
• Trabectedin (Yondelis) patient drug information (Chemocare)
• Trabectedin (Yondelis) patient drug information (UpToDate)

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 Health Canada indication

• 2010-05-13: Initial notice of compliance

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