07/06/2011 Human medicines European Public Assessment Report (EPAR): Yondelis,
trabectedin
Revision: 6, Authorised .
The CHMP, having reviewed the evidence of compliance with the specific obligations submitted by the MAH and having reassessed the benefit/risk profile of the medicinal product, concluded that the benefit/risk balance for the product remains favourable.
Pharmaco-therapeutic Group .
Antineoplastic agents .
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.