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EMA Started a Review of Trabectedin

The review is initiated after an interim analysis of the results from the OVC-3006 study conducted in patients with ovarian cancer
03 Mar 2020
Ovarian Cancer

European Medicines Agency (EMA) announced on 28 February 2020 that its Committee for Medicinal Products for Human Use (CHMP) has started a review of trabectedin (Yondelis), the cancer medicine used to treat ovarian cancer and soft-tissue sarcoma. The review started after a clinical study OVC-3006, which investigated 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 did not live longer than patients given pegylated liposomal doxorubicin alone.

Although there were some differences in the types of patients enrolled in the OVC-3006 study compared with those if the study on which the authorisation of Yondelis for ovarian cancer was based, the OVC-3006 study also included patients for whom Yondelis would be indicated. EMA will therefore review the available data to assess whether the results from the OVC-3006 study have an impact on the authorised use of Yondelis in patients with ovarian cancer.

This review does not cover the use of Yondelis for the treatment of soft-tissue sarcoma.

While the review is ongoing, Yondelis can continue to be used for the treatment of both ovarian cancer and soft-tissue sarcoma, according to the authorised product information. Patients who have any questions about their treatment should speak to their doctor.

Yondelis is used with pegylated liposomal doxorubicin to treat platinum sensitive, relapsed ovarian cancer. It is also used to treat adults with advanced soft-tissue sarcoma when the cancer had started to spread and treatment with anthracyclines and ifosfamide have stopped working, or in patients who cannot be given these medicines.

More information about Yondelis is available here.

The review of Yondelis has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004. This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.

The review is being carried out by the CHMP, responsible for questions concerning medicines for human use, which will adopt the EMA’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States. 

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