This is a summary of the European public assessment report (EPAR) for Yondelis. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Yondelis.
Therapeutic Indication
### Therapeutic indication Yondelis is indicated for the treatment of patients with advanced soft-tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
Therapeutic Area (MeSH)
N/AATC Code
L01CX01
ATC Item
trabectedin
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| trabectedin | N/A | 曲贝替定 |
EMA Name
Yondelis
Medicine Name
Yondelis
Aliases
N/ANo risk management plan link.
