Overview
Trabectedin, also referred as ET-743 during its development, is a marine-derived antitumor agent discovered in the Carribean tunicate Ecteinascidia turbinata and now produced synthetically. Trabectedin has a unique mechanism of action. It binds to the minor groove of DNA interfering with cell division and genetic transcription processes and DNA repair machinery. It is approved for use in Europe, Russia and South Korea for the treatment of advanced soft tissue sarcoma. It is currently under evaluation for the treatment of breast cancer, prostate cancer, in addition to pediatric sarcomas. Both the European Commission and the U.S. Food and Drug Administration (FDA) have approved trabectedin as an orphan drug in soft tissue sarcomas and ovarian cancer. On October 23, 2015, the FDA approved trabectedin, (as Yondelis), for the treatment of specific soft tissue sarcomas.
Indication
用于治疗急性淋巴母细胞白血病、晚期软组织肉瘤及复发卵巢癌。
Associated Conditions
- Metastatic Leiomyosarcoma
- Metastatic Liposarcoma
- Platinum Sensitive Relapsed Ovarian Cancer
- Unresectable Leiomyosarcoma
- Unresectable Liposarcoma
Research Report
Trabectedin (Yondelis®): A Comprehensive Monograph on a Marine-Derived Antineoplastic Agent
Section 1: Executive Summary
Trabectedin, marketed as Yondelis®, represents a significant milestone in oncologic drug development, exemplifying the therapeutic potential harbored within marine ecosystems. Identified by its DrugBank ID DB05109, this small molecule is a complex tetrahydroisoquinoline alkaloid, originally isolated from the Caribbean tunicate Ecteinascidia turbinata and now produced via a scalable semi-synthetic process. Its classification as an alkylating agent belies a unique and multifaceted mechanism of action that distinguishes it from conventional cytotoxic drugs. Trabectedin covalently binds to the minor groove of DNA, inducing a structural distortion that triggers a cascade of events leading to cell cycle arrest and apoptosis. Critically, it interferes with cellular machinery by poisoning the transcription-coupled nucleotide excision repair (TC-NER) pathway and exploiting deficiencies in homologous recombination repair (HRR), providing a strong rationale for its activity in specific tumor types. Furthermore, Trabectedin exerts profound effects on the tumor microenvironment (TME), selectively depleting immunosuppressive tumor-associated macrophages (TAMs).
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/10/11 | Phase 3 | Terminated | |||
2016/09/16 | Phase 3 | Completed | |||
2016/07/07 | N/A | Completed | PharmaMar | ||
2016/06/20 | Phase 1 | Completed | |||
2016/06/08 | N/A | Completed | |||
2016/02/03 | Phase 3 | Completed | |||
2015/07/27 | N/A | UNKNOWN | Technical University of Munich | ||
2015/03/25 | Phase 1 | Completed | |||
2015/03/20 | N/A | Completed | Grupo Español de Investigación en Cáncer de Ovario | ||
2015/02/20 | N/A | Completed | PharmaMar, Spain |
FDA Drug Approvals
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