People with advanced liposarcomas in Europe may now be able to receive Halaven(R) (eribulin), the first and only single agent therapy to show a significant survival advantage in this type of soft tissue sarcoma.
The European Commission has approved a variation to the terms of the Marketing Authorisation (MA) of eribulin for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.
The decision is based on the results of Study 309 which is now published in The Lancet. This is a randomised, open-label multicentre Phase III study comparing the efficacy and safety of eribulin mesilate to dacarbazine in 452 patients (aged 18 or over) with leiomyosarcomas or liposarcomas.
Data show a median overall survival improvement of 2.6 months (13.5 months versus 11.5 months) in patients with leiomyosarcomas or liposarcomas treated with eribulin versus dacarbazine.
A subset of people with unresectable advanced or metastatic liposarcomas treated with eribulin lived a median 7.2 months longer than those treated with dacarbazine.
‘This decision marks an important milestone for people in Europe with advanced liposarcomas. There are currently limited treatment options available, but now, we are a step closer to being able to offer them a treatment with a proven overall survival benefit.
‘Eribulin was the first-ever single agent therapy to show such a survival benefit, which makes today’s news all the more important for patients and clinicians across Europe,’ commented Patrick Schöffski, University Hospitals Leuven, Belgium.
