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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/29 | Phase 2 | Recruiting | |||
2024/02/16 | Phase 3 | 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 | |||
2020/05/19 | N/A | Completed |
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 |
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