Yondelis

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
Under evaluation

Overview

Review of Yondelis started

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.

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

Key facts

Approved name
Yondelis
International non-proprietary name (INN) or common name

trabectedin

Associated names
Yondelis
Class
Antineoplastic agents
Reference number
EMEA/H/A-20/1493/C/0773/0060
Type
Article 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.

Status
Under evaluation
Opinion date
27/02/2020

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

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