NDAINTRAVENOUSPOWDERPriority Review
Approved
Oct 2015
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
21
Data completeness
6/8 — Strong
Priority Review
YONDELIS (trabectedin) by Johnson & Johnson is alkylating activity [moa]. Approved for alkylating drug [epc]. First approved in 2015.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
YONDELIS (trabectedin) is a small-molecule alkylating agent approved in 2015 for soft tissue sarcomas, ovarian cancer, and other rare malignancies. It works by binding to DNA and disrupting gene transcription, inducing apoptosis in tumor cells. The drug is administered intravenously as a powder formulation.
$0.578MPart D
LOE Approaching2.2 years to LOEWith LOE approaching in 2.2 years and modest Part D spending ($578K in 2023), the brand team is likely consolidating resources and preparing for generic entry rather than scaling.
Mechanism of Action
Alkylating Activity
Pharmacologic Class:
Alkylating Drug
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (21)
Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients
Started Oct 2023
7 enrolled
Soft Tissue Sarcoma
Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma
Started Sep 2021
16 enrolled
Mesenchymal Chondrosarcoma
Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma
Started Jul 2021
175 enrolled
Dedifferentiated Liposarcoma
SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients
Started Jan 2021
37 enrolled
Ewing Sarcoma
Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
Started Mar 2020
29 enrolled
SarcomaSarcoma Metastatic
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.