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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/22 | Not Applicable | Not yet recruiting | |||
2024/07/29 | Phase 2 | Recruiting | |||
2024/02/16 | Phase 3 | Active, not recruiting | |||
2023/05/22 | N/A | Completed | Grupo Español de Investigación en Cáncer de Ovario | ||
2022/10/28 | Phase 3 | Recruiting | |||
2022/06/27 | Phase 2 | Active, not recruiting | |||
2024/05/22 | Phase 2 | Not yet recruiting | Asoc Grupo Espanol De Investigacion En Sarcomas | ||
2021/07/28 | Phase 3 | Terminated | |||
2021/03/11 | Phase 2 | Recruiting | Mario Negri Institute for Pharmacological Research | ||
2020/09/01 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Janssen Products, LP | 59676-610 | INTRAVENOUS | 0.05 mg in 1 mL | 12/31/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/17/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| YONDELIS Powder for Injection 1mg/vial | SIN13661P | INJECTION, POWDER, FOR SOLUTION | 1.0mg/vial | 6/19/2009 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| YONDELIS trabectedin 1 mg powder for solution for infusion vial | 332001 | Medicine | A | 4/22/2021 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| YONDELIS | Valeo Pharma Inc | 02351528 | Powder For Solution - Intravenous | 1 MG / VIAL | 8/5/2010 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| TRABECTEDINA EVER PHARMA 1 MG POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN EFG | Ever Valinject Gmbh | 88899 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario,Medicamento Sujeto A Prescripción Médica | Commercialized |
| TRABECTEDINA ACCORD 0,25 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | 1241902001 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
| TRABECTEDINA SUN 1 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | 88408 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| TRABECTEDINA ACCORD 1 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | 1241902002 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
| TRABECTEDINA STADA 1 MG POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN EFG | Laboratorio Stada S.L. | 89147 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| YONDELIS 0,25 mg POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION | 07417001 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| TRABECTEDINA STADA 0,25 MG POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN EFG | Laboratorio Stada S.L. | 89148 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| TRABECTEDINA EVER PHARMA 0,25 MG POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN EFG | Ever Valinject Gmbh | 88898 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario,Medicamento Sujeto A Prescripción Médica | Commercialized |
| TRABECTEDINA TEVA 0,25 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | 86916 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| TRABECTEDINA TEVA 1 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | 86917 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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