The positive opinion for licence extension to eribulin (Halaven) from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is based on pivotal Phase III data which show a median 7.2 month increase in overall survival compared to dacarbazine (15.6 months versus 8.4 months, HR = 0.511; 95% CI 0.346-0.753; P=0.0006) for people with unresectable advanced or metastatic liposarcomas.

Eribulin is the first and only single agent therapy to show a significant survival advantage in this type of soft tissue sarcoma.  

“Eribulin has been shown to extend the lives of adults with specific types of progressive soft tissue sarcoma, which are rare and have a high rate of mortality. This positive opinion is welcomed by sarcoma specialists in Europe, who have few options to treat these patients. These data are a clinically meaningful result given the significant unmet need. This is the first and only time that we have been able to demonstrate an overall survival benefit in soft tissue sarcoma in a large Phase III trial, which mirrors the results for eribulin in advanced breast cancer,” said Patrick Schöffski, Head of the Department of General Medical Oncology, University Hospitals Leuven, Belgium.

Eribulin shows a median overall survival improvement of 2.6 months (13.5 months versus 11.5 months) in patients with leiomyosarcomas or liposarcomas (L-type soft tissue sarcomas) when compared with dacarbazine, an active treatment option (HR=0.768, 95% CI 0.618–0.954; P=0.017).

There were no unexpected or new safety findings; the toxicity profile is consistent with the known safety profile of eribulin.

The pivotal study results were published in The Lancet, February 2016.

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.

Eribulin also induces vascular remodelling, suppresses migration and invasion of cancer cells, and reverses the epithelial-to-mesenchymal transition in many cancer cell lines.

Only 50% of people with soft tissue sarcomas are expected to live five years. 

29,000 people are diagnosed with soft tissue sarcomas each year, approximately 1% of all cancers diagnosed in Europe. 

Liposarcomas (adipocytic sarcomas) originate in fat cells and can occur anywhere in the body. 

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.

Licence was granted in Japan to extend the indication of eribulin to treat patients with soft tissue sarcomas in February 2016.

Source: Eisai