Yondelis approved due to cost-sharing scheme

NICE has overturned its previous guidance on Yondelis (trebactedin) to recommend access to the drug for some cancer patients.

The new final guidance recommends trabectedin for the treatment of certain patients with advanced soft tissue sarcoma, reversing the Institute’s earlier negative assessment.

The recommendation was made following the manufacturer PharmaMar’s agreement to meet the costs of the drug when it is needed beyond the fifth cycle of treatment.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “It’s thought between 500 and 600 people live with advanced soft tissue sarcoma in England and Wales. We are pleased to be able to recommend trabectedin for NHS use as it will provide a treatment option for some patients.”

NICE has recommended the use of trabectedin as a treatment for people with advanced soft tissue sarcoma if treatment with anthracyclines and ifosfamide has failed or they are intolerant to these therapies.

Roger Wilson, from Sarcoma UK, commented: “It has been a challenging journey for everyone concerned, doctors, patients, regulators and the manufacturer. This news encourages everyone as it opens the way for a new era in the treatment of advanced soft tissue sarcoma, for which there have been few advances in over 20 years.

“Few pharmaceutical companies pay much regard to rare cancers so I would pay tribute to PharmaMar for their determination to see Yondelis into clinical use, and to thank them for the patient access scheme which makes it possible.”

Soft tissue sarcomas are tumours that develop in the soft, supporting tissue in the body, such as fat, muscle and blood vessels and can occur anywhere in the body.

Trabectedin (Yondelis) is an intravenous drug that works by damaging the DNA in cancer cells, making them unable to grow and spread. It is administered over 24-hours with a three week interval between cycles.

Research has shown that the drug can extend the life of a person with advanced soft tissue sarcoma by at least three more months than current NHS treatment.

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