Yondelis

trabectedin

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This is a summary of the European public assessment report (EPAR) for Yondelis. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Yondelis.

What is Yondelis?

Yondelis is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance trabectedin.

What is Yondelis used for?

Yondelis is used to treat adults with two types of cancer:

  • advanced soft-tissue sarcoma, a type of cancer that develops from the soft, supporting tissues of the body. ‘Advanced’ means that the cancer has started to spread. Yondelis is used when treatment with anthracyclines and ifosfamide (other anticancer medicines) have stopped working, or in patients who cannot be given these medicines;
  • ovarian cancer (cancer of the ovaries) that has relapsed (come back after previous treatment) and is sensitive to medicines containing platinum. Yondelis is used in combination with pegylated liposomal doxorubicin (PLD, another anticancer medicine).

Because the numbers of patients with soft-tissue sarcoma and ovarian cancer are low, the diseases are considered ‘rare’, and Yondelis was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 30 May 2001 (for soft-tissue sarcoma) and on 17 October 2003 (for ovarian cancer).

The medicine can only be obtained with a prescription.

How is Yondelis used?

Yondelis must be given under the supervision of a doctor who is experienced in the use of chemotherapy (medicines to treat cancer). It should only be used by qualified oncologists (cancer specialists) or other health professionals who are specialised in giving cytotoxic (cell-killing) medicines.

For soft-tissue sarcoma, the recommended dose of Yondelis is 1.5 mg per square metre of body surface area (calculated using the patient’s height and weight), given as a single infusion lasting 24 hours every three weeks. For ovarian cancer, it is given at a dose of 1.1 mg/m2 every three weeks as an infusion lasting three hours, immediately after the PLD infusion.

Treatment carries on for as long as the patient shows a benefit. It is recommended that Yondelis be given through a central venous line (a thin tube leading from the skin into the large veins just above the heart). To prevent vomiting and to protect the liver, patients must receive an infusion of corticosteroids such as dexamethasone before treatment. If the patient’s blood counts are abnormal, infusion with Yondelis should be delayed, the dose of Yondelis should be reduced or other medicines can be used to treat the blood problems. For more information, see the summary of product characteristics (also part of the EPAR).

How does Yondelis work?

The active substance in Yondelis, trabectedin, is an anticancer medicine. It is a synthetic version of a substance that was originally extracted from a species of tunicate or ‘sea squirt’ (a marine animal). Cancer is a disease where cells divide too quickly, usually because the way their genes work is faulty. Trabectedin works by attaching to the DNA, the chemical molecule that makes up genes, and preventing some genes in human cells from increasing their activity. This can prevent the cells from dividing too quickly, slowing down the growth of various types of cancer.

How has Yondelis been studied?

For soft-tissue sarcoma, Yondelis has been studied in one main study involving 266 patients with liposarcoma (a sarcoma originating in fat cells) or leiomyosarcoma (a sarcoma originating in ‘smooth’ or involuntary muscle cells) that was advanced or metastatic (had spread to other parts of the body). All of the patients had been treated previously with an anthracycline and ifosfamide but this treatment had stopped working. The study compared two different dosing schedules of Yondelis: three times per month, or once every three weeks.

For ovarian cancer, Yondelis in combination with PLD was compared with PLD alone in one main study involving 672 women whose disease had come back or got worse after previous treatment. Around two-thirds of the patients had cancer that was sensitive to platinum-containing medicines.

In both studies, the main measure of effectiveness was how long the patients lived without their disease getting worse.

What benefit has Yondelis shown during the studies?

For soft-tissue sarcoma, Yondelis was more effective when it was given once every three weeks than when it was given with the alternative dosing schedule. Patients receiving it once every three weeks lived for an average of 3.8 months without their disease getting worse, compared with 2.1 months in those receiving Yondelis three times per month.

For ovarian cancer, the combination of Yondelis and PLD was more effective than PLD alone: patients receiving the combination treatment lived for an average of 7.3 months without their disease getting worse, compared with 5.8 months in those receiving PLD alone. The effect of Yondelis was more pronounced in the women whose cancer was sensitive to platinum-containing medicines.

What is the risk associated with Yondelis?

Most patients treated with Yondelis can be expected to have side effects. Around 10% of those patients treated with Yondelis as a single agent and 25% treated with Yondelis in combination therapy can be expected to have serious side effects. The most common side effects of any severity were neutropenia (low levels of neutrophils, a type of white blood cell), nausea (feeling sick), vomiting, increase in liver enzymes, anaemia (low red-blood-cell counts), tiredness, thrombocytopenia (low blood platelet counts), loss of appetite and diarrhoea. Fatal side effects have occurred in 1.9% and 0.9% of patients treated with Yondelis as a single agent and combination therapy respectively.

Yondelis must not be used in people who are hypersensitive (allergic) to trabectedin or any of the other ingredients. It must not be used in patients who have any serious or uncontrolled infection, in combination with the vaccine for yellow fever, or in breast-feeding women.

Why has Yondelis been approved?

The CHMP concluded that Yondelis’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Yondelis has been authorised under ‘exceptional circumstances’. This means that because soft-tissue sarcoma is rare, it has not been possible to obtain complete information about Yondelis. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for Yondelis?

The company that makes Yondelis will continue to assess which patients with soft-tissue sarcoma are more likely to respond to the medicine.

Other information about Yondelis

The European Commission granted a marketing authorisation valid throughout the European Union for Yondelis on 17 September 2007.

For more information about treatment with Yondelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Yondelis : EPAR - Summary for the public BG = bălgarski 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public ES = español 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public CS = čeština 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public DA = dansk 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public DE = Deutsch 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public ET = eesti keel 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public EL = elliniká 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public EN = English 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public FR = français 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public IT = italiano 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public LV = latviešu valoda 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public LT = lietuvių kalba 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public HU = magyar 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public MT = Malti 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public NL = Nederlands 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public PL = polski 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public PT = português 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public RO = română 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public SK = slovenčina 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public SL = slovenščina 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public FI = suomi 07/07/2009 10/09/2012
Yondelis : EPAR - Summary for the public SV = svenska 07/07/2009 10/09/2012

This EPAR was last updated on 26/05/2014 .

Authorisation details

Product details

Product details for Yondelis
NameYondelis
Agency product numberEMEA/H/C/000773
Active substance

trabectedin

International non-proprietary name (INN) or common name

trabectedin

Therapeutic area Ovarian NeoplasmsSarcoma
Anatomical therapeutic chemical (ATC) code L01CX01
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Exceptional Circumstances

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for Yondelis
Marketing-authorisation holder

Pharma Mar S.A.

Revision12
Date of issue of marketing authorisation valid throughout the European Union17/09/2007

Contact address:

Pharma Mar S.A.
Polígono Industrial La Mina
Avda. de los Reyes, 1
E-28770 Colmenar Viejo (Madrid)
Spain

Product information

Product information

20/03/2014  Yondelis -EMEA/H/C/000773 -S/0037

Name Language First published Last updated
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014
Yondelis : EPAR - Product Information SV = svenska 07/07/2009 26/05/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011
Yondelis : EPAR - All Authorised presentations SV = svenska 12/10/2007 07/06/2011

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Yondelis is indicated for the treatment of patients with advanced soft-tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.

Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Yondelis : EPAR - Procedural steps taken before authorisation SV = svenska 12/10/2007  
Yondelis : EPAR - Scientific Discussion SV = svenska 12/10/2007  

Authorised

This medicine is approved for use in the European Union