Swedish Orphan Biovitrum distributes this product in the Nordic and the Baltic countries, and in Central and Eastern Europe.
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 patients with advanced soft tissue sarcoma, a type of cancer that develops from the soft, supporting tissues of the body. It is used when treatment with anthracyclines and ifosfamide (other anticancer medicines) have stopped working, or in patients who cannot be given these medicines. Because the number of patients with soft tissue sarcoma is low, the disease is considered ‘rare’, and Yondelis was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 30 May 2001.
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. It should only be used by qualified oncologists (cancer specialists) or other health professionals who are specialised in giving cytotoxic (cell-killing) medicines. The recommended dose of Yondelis is 1.5 mg per square meter of body surface (calculated using the patient’s height and weight), given as a single intravenous infusion (drip into a vein) over 24 hours every three weeks. 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, an infusion of dexamethasone (a corticosteroid) should be given before each Yondelis dose. Infusion with Yondelis should be delayed or the dose of Yondelis reduced if the patient’s blood counts are abnormal (such as low counts of white blood cells or platelets). It should be used with caution in patients who have problems with their liver. Yondelis must not be used in children until further information is available. It should not be used in those who have high bilirubin levels (a marker of certain liver problems) or who have severe problems with their kidneys. 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 chemical 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 turning up their activity. This can prevent the cells from dividing too quickly, slowing down the growth of various types of cancer, including sarcoma.
How has Yondelis been studied?
The effects of Yondelis were first tested in experimental models before being studied in humans. The effects of Yondelis were also 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. The main measure of effectiveness was the time until the disease got worse. The study was still ongoing at the time of assessment.
What benefit has Yondelis shown during the studies?
Yondelis was more effective when it was given once every three weeks than the alternative dosing schedule. In patients receiving it once every three weeks, it took an average of 3.8 months for their disease to get worse, compared with 2.1 months in those receiving Yondelis three times per month.
What is the risk associated with Yondelis?
The most common side effects with Yondelis (seen in more than 1 patient in 10) are increased blood levels of creatine phosphokinase (marker of muscle breakdown) and of creatinine (a marker of kidney problems), decreased blood levels of albumin (a marker of liver problems), neutropenia (low levels of neutrophils, a type of white blood cell), thrombocytopenia (low levels of platelets in the blood), anaemia (low levels of red blood cells), leucopenia (low levels of leucocytes, a type of white blood cell), headache, vomiting, nausea (feeling sick), constipation, anorexia (loss of appetite), fatigue (tiredness), asthenia (weakness), hyperbilirubinaemia (high levels of bilirubin in the blood) and increased levels of liver enzymes in the blood (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and gamma-glutamyltransferase). For the full list of all side effects reported with Yondelis, see the Package Leaflet. Yondelis should not be used in people who may be hypersensitive 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 Committee for Medicinal Products for Human Use (CHMP) concluded that Yondelis’s benefits are greater than its risks for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. The Committee noted that evidence of Yondelis’s effects is mainly based on the treatment of liposarcoma and leiomyosarcoma. The Committee recommended that Yondelis be given marketing authorisation. Yondelis has been authorised under “Exceptional Circumstances”. This means that because the disease is rare, it has not been possible to obtain complete information about Yondelis. Every year, the European Medicines Agency (EMEA) 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 are more likely to respond to the medicine, and will carry out a study to investigate the effects of Yondelis in patients with a type of cancer called ‘myxoid liposarcoma’.
Other information about Yondelis:
The European Commission granted a marketing authorisation valid throughout the European Union for Yondelis to Pharma Mar, S.A. on 17 September 2007.