European Medicines Agency begins review of trabectedin (Yondelis)

The review was started because the interim results of a clinical study (OVC-3006) in ovarian cancer showed no overall survival benefit for patients treated with trabectedin plus pegylated liposomal doxorubicin (PLD) over PLD alone. The study was terminated early.

SPS commentary:

Trabectedin is licensed in the UK, for use in combination with PLD, for the treatment of patients with relapsed platinum-sensitive ovarian cancer. Although there were some differences in the types of patients enrolled in study OVC-3006 and the study that its current approval was based on, OVC-3006 did include some patients for whom trabectedin would be currently indicated. The European Medicines Agency will therefore review the available data to assess whether the results from study OVC-3006 have an impact on the authorised use of trabectedin in patients with ovarian cancer.


This review will not cover its use for the treatment of soft-tissue sarcoma.


European Medicines Agency