Last reviewed · How we verify
Yondelis (TRABECTEDIN)
Yondelis works by binding to DNA and causing interstrand crosslinks, thereby inhibiting cancer cell growth.
At a glance
| Generic name | TRABECTEDIN |
|---|---|
| Sponsor | Janssen Prods |
| Drug class | Alkylating Drug [EPC] |
| Target | Proto-oncogene tyrosine-protein kinase Src |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2015 |
Mechanism of action
Trabectedin is an alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in bending of the DNA helix towards the major groove. Adduct formation triggers cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death.
Approved indications
- Leiomyosarcoma
- Liposarcoma
- Malignant tumor of ovary
- Soft or Connective Tissue Sarcoma
Common side effects
- Nausea
- Fatigue
- Vomiting
- Constipation
- Decreased appetite
- Diarrhea
- Peripheral edema
- Dyspnea
- Headache
- Increased liver tests
- Thrombocytopenia
- Neutropenia
Key clinical trials
- Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma (PHASE2)
- Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma (PHASE2)
- Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma (PHASE2)
- Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS (PHASE2)
- Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients (NA)
- A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young Adult Patients With Recurrent Soft Tissue Sarcomas (PHASE1)
- Study on Trabectedin in Combination With Pioglitazone in Patients Myxoid Liposarcomas With Stable Disease After T Alone. (PHASE2)
- Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working (PHASE2,PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Yondelis CI brief — competitive landscape report
- Yondelis updates RSS · CI watch RSS
- Janssen Prods portfolio CI