24.07.2020 - CHMP opinion

EMA has recommended that the use of Yondelis (trabectedin) in treating ovarian cancer remain unchanged following a review of a study that investigated Yondelis as a third-line treatment in patients with ovarian cancer. However, the study results will be included in the medicine’s product information to provide healthcare professionals with the most up-to-date information on the effects of Yondelis in patients with ovarian cancer.

28.02.2020 - Procedure startet

EMA’s human medicines committee (CHMP) has started a review of the cancer medicine Yondelis (trabectedin), used to treat ovarian cancer (cancer of the ovaries) and soft-tissue sarcoma (a type of cancer that develops from the soft, supporting tissues of the body). The review started after a clinical study (OVC-3006) investigating the use of Yondelis in patients with ovarian cancer was stopped ahead of time, because an interim analysis of the results showed that, overall, patients treated with Yondelis plus pegylated liposomal doxorubicin (PLD, another cancer medicine) did not live longer than patients given PLD alone.Details zu dem Verfahren können unter folgendem Link bei der Europäischen Arzneimittel-Agentur (EMA) abgerufen werden:

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):