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Yondelis
Published
Product name
Yondelis
Active ingredient
Trabectedin
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Yondelis (trabectedin) was approved for the following therapeutic use:
Yondelis is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen
How this medicine works
Trabectedin binds to the minor groove of deoxyribonucleic acid (DNA), bending the helix to the major groove. This binding to DNA triggers a cascade of events affecting several transcription factors, DNA binding proteins, and DNA repair pathways, resulting in perturbation of the cell cycle.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Yondelis was considered favourable for the therapeutic use approved.
ARTG details: 332000, 332001