On 21st December 2009,  the National Institute for Health and Clinical Excellence (NICE) has recommended Yondelis ® (trabectedin) as a treatment option for people with advanced soft tissue sarcoma, a particularly rare form of cancer. The positive recommendation follows PharmaMar’s decision to offer a groundbreaking patient access scheme which limits the overall cost exposure to the NHS.

Commenting on NICE’s decision, Pharmamar made a statement :

“We are delighted that NICE has recommended trabectedin for use in advanced soft tissue sarcoma.  This decision is great news for NHS patients, who will now be able to gain access to trabectedin if their clinician recommends it.

“Trabectedin represents an important step forward in the treatment of soft tissue sarcoma and NICE’s decision means that clinicians will be able to prescribe a treatment which is available as standard in other countries.

“Our patient access scheme enables clinicians to prescribe with the confidence that the overall cost to the NHS will be limited. We are proud to play our part in making this important treatment available to all NHS patients who could benefit.”


1.    On 21 December 2009, the National Institute for Health and Clinical Excellence (NICE) issued final guidance on trabectedin for the treatment of advanced soft tissue sarcoma, in which states:

Trabectedin is recommended as a treatment option for people with
advanced soft tissue sarcoma if:
•    treatment with anthracyclines and ifosfamide has failed or
•    they are intolerant of or have contraindications for treatment with anthracyclines and ifosfamide
and
•    the acquisition cost of trabectedin for treatment needed after the fifth cycle is met by the manufacturer.

2.    About trabectedin

Trabectedin (Yondelis ®) is an alkylating agent, which affects cancer cells by damaging DNA. Trabectedin was developed by PharmaMar and was licenced for use in the UK in 2007.  Trabectedin has a UK marketing authorisation 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 marketing authorisation was granted under ‘exceptional circumstances’. The summary of product characteristics (SPC) states that ‘efficacy data are based mainly on liposarcoma and leiomyosarcoma patients’.  Trabectedin has been designated an orphan drug by the European Commission (EC) for soft tissue sarcoma and ovarian cancer.

3.    About sarcoma

Sarcomas are cancers of connective tissue – bones, muscle, fatty tissue, cartilage, nerves etc.  Sarcomas account for about 1% of all cancers diagnosed – about 3,000 cases a year in the UK. There are more than fifty different sub-types of sarcoma.

4.    About PharmaMar

PharmaMar is a biopharmaceutical company, which is devoted to advancing the treatment of cancer through the development, discovery and marketing of innovative drugs of marine origin.