publication date: May. 6, 2016

Drugs and Targets

Eribulin Receives EU Approval For Unresectable Liposarcoma 

 

The European Commission approved a variation to the terms of the Marketing Authorisation of eribulin for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy for advanced or metastatic disease.

The decision is based on the results of Study 309, which was published in The Lancet. The randomized, open-label multicenter phase III study compared 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 (HR=0.768, 95% CI 0.618-0.954; P=0.017). 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). Eribulin’s toxicity profile was consistent with prior experience, with no unexpected or new safety findings.

Eribulin, developed by Eisai Co., Ltd., 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.

In January 2016, FDA approved eribulin for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. License was granted … Continue reading 42-18 Eribulin Receives EU Approval for Unresectable Liposarcoma

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