European Commission approves Halaven (eribulin) for treatment of advanced liposarcoma in Europe

Eribulin is the first and only single agent to show a significant improvement in overall survival for people with advanced liposarcomas.

People with advanced liposarcomas in Europe may now be able to receive Halaven® (eribulin), the first and only single agent therapy to show a significant survival advantage in this type of soft tissue sarcoma.¹ 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.¹ 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 (HR=0.768, 95% CI 0.618-0.954; P=0.017).¹ 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 (15.6 months versus 8.4 months median OS, HR = 0.511; 95% CI 0.346-0.753; P=0.0006).¹ Eribulin's toxicity profile was consistent with prior experience, with no unexpected or new safety findings.¹

"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," comments Patrick Schöffski, University Hospitals Leuven, Belgium.

Eribulin is a microtubule-dynamics inhibitor, structurally modified analogue of halichondrin B, originally isolated from the marine sponge Halichondria okadai. Its mode of action is distinct from other tubulin inhibitors and involves binding to specific sites on the growing positive ends of microtubules to inhibit their growth. Recent data for blood perfusion show that eribulin may lead to remodelling of the tumour vasculature, resulting in an oxygenated environment.² Cancer cells thrive in a deoxygenated (hypoxic) environment and therefore improving tumour perfusion may lead to a decrease in tumour metastatic potency.³

Only 50% of people with soft tissue sarcomas are expected to live for five years.⁴ 29,000 people are diagnosed with soft tissue sarcomas each year, approximately 1% of all cancers diagnosed in Europe.⁵ Liposarcomas (adipocytic sarcomas) originate in fat cells and can occur anywhere in the body.⁶

Eribulin is also indicated for the treatment of women with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.⁷

"At Eisai, our first thought is with people in Europe who now have access to this new treatment and the benefit it may have for them and their families. This is the second form of cancer in which eribulin has demonstrated an overall survival benefit when compared to active therapy. We are encouraged by the Commission's decision, and will continue with our commitment to develop and discover products that have a positive impact on patients and their families," comments Gary Hendler, Chief Commercial Officer Oncology Business Group, Chairman and CEO EMEA.

In January 2016 the Food and Drug Administration (FDA) approved eribulin for the treatment of people in the US with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. License was granted in Japan to extend the indication of eribulin to treat patients with soft tissue sarcomas in February 2016.