Eisai's Halaven gains new cancer indication in Europe

Eisai's Halaven (eribulin) cancer drug has a new use in Europe after it was approved for adults with advanced liposarcomas.

The European Commission's approval of a new indication, in adults with unresectable liposarcomas who have received prior anthracycline-containing therapy (unless unsuitable) for advanced or metastatic disease, follows a positive opinion from the CHMP just over a month ago.

Halaven is an important drug for Eisai, predicted by Druganalyst to accrue annual sales of around 57 billion yen ($530 million) by 2019.

The decision was based on the phase 3 Study 309 showing 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.

It is already approved in second line for women with locally advanced or metastatic breast cancer. However in 2012 England's NICE ruled it was not a cost-effective treatment for routine National Health Service funding.

Halaven was then paid for in England by the Cancer Drugs Fund – but was slated to be removed from the fund last year on cost grounds. After negotiations between Eisai and the Department of Health, it was reinstated on the fund last summer.

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. Cancer cells thrive in a deoxygenated environment and therefore improving tumour perfusion may lead to a decrease in tumour metastatic potency.

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