Yondelis
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
Authorised uses of cancer medicine Yondelis unchanged following review of new data
On 23 July 2020, EMA 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.
An analysis of study OVC-3006 investigating the use of Yondelis plus pegylated liposomal doxorubicin (PLD, another cancer medicine) in patients with ovarian cancer was carried out while the study was still ongoing and showed that, overall, patients treated with Yondelis plus PLD did not live longer than patients given PLD alone. As a result, the study was terminated ahead of time.
EMA’s human medicines committee (CHMP) assessed the data and concluded that the results available are not robust enough to draw firm conclusions. Available evidence from the study does not put into question the benefits and risks of Yondelis in its currently authorised uses. Further, there are key differences between OVC-3006 and the study that supported the authorisation of Yondelis (OVA-301). The main difference is that patients in study OVC-3006 had a more advanced disease and had been more heavily treated than those included in OVA-301. In addition, a significant proportion of patients in study OVC-3006 had ovarian cancer that was resistant to medicines containing platinum, while Yondelis is currently authorised for platinum-sensitive ovarian cancer.
When considering Yondelis’ safety, the CHMP noted that in the OVC-3006 study patients treated with Yondelis and PLD had more side effects and more severe ones than those treated with PLD only; however, the committee considered that a higher occurrence of side effects is not unexpected with combination treatments compared to treatments used alone.
The CHMP recommended that the results of the study be included in the summary of product characteristics of Yondelis so that healthcare professionals have the most up-to-date information when prescribing the medicine.
Key facts
|
About this medicine
|
|
|---|---|
| Approved name |
Yondelis
|
| International non-proprietary name (INN) or common name |
trabectedin
|
| Associated names |
Yondelis
|
| Class |
Antineoplastic agents
|
|
About this procedure
|
|
|---|---|
| Current status |
European Commission final decision
|
| 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. |
| Authorisation model |
Centrally authorised product(s)
|
|
Key dates and outcomes
|
|
|---|---|
| CHMP opinion date |
24/07/2020
|
| EC decision date |
24/09/2020
|
All documents
Procedure started
Yondelis Article-20 procedure - Annex III (PDF/473.21 KB)
First published: 24/07/2020
Yondelis Article-20 procedure - Notification (PDF/822.4 KB)
First published: 28/02/2020
Yondelis Article-20 procedure - CHMP list of questions (PDF/121.05 KB)
First published: 28/02/2020
EMA/CHMP/88965/2020
Yondelis Article-20 procedure - Review started (PDF/127.78 KB)
First published: 28/02/2020
EMA/95220/2020
Under evaluation
European Commission final decision
Yondelis Article-20 procedure - Annex I-III
First published: 09/10/2020
Yondelis Article-20 procedure - Annex IV (PDF/92.35 KB)
First published: 09/10/2020
Yondelis Article-20 procedure - Assessment report (PDF/3.85 MB)
First published: 30/09/2020
EMA/470721/2020
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.