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 cancer medicine that contains the active substance trabectedin. It is available as a powder that is made up into a solution for infusion (drip into a vein).
What is Yondelis used for?
Yondelis is used to treat adults with two types of cancer:
•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 cancer medicine).
Because the numbers of patients with
The medicine can only be obtained with a prescription.
© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.
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
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 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 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
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 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
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. For the full list of all side effects reported with Yondelis, see the package leaflet.
Yondelis must not be used in patients who have any serious or uncontrolled infection, in combination with the vaccine for yellow fever, or in
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 was originally authorised under ‘exceptional circumstances’, because, limited information was available at the time of approval on
What measures are being taken to ensure the safe and effective use of Yondelis?
A risk management plan has been developed to ensure that Yondelis is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Yondelis, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about Yondelis
The European Commission granted a marketing authorisation valid throughout the European Union for Yondelis on 17 September 2007.
The full EPAR for Yondelis can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Yondelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The summary of the opinion of the Committee for Orphan Medicinal Products for Yondelis can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
This summary was last updated in