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Eisai’s Halaven recommended for European approval

Published on 04/04/16 at 01:32pm

Eisai has received a positive opinion from the European Commission’s CHMP for Halaven (eribulin) as a second-line therapy for patients with unresectable liposarcomas, after anthracycline containing therapy.

The recommendation is based on pivotal Phase III data which show a median 7.2 month increase in overall survival compared to dacarbazine, at 15.6 months versus 8.4 months for people with unresectable advanced or metastatic liposarcomas.

Halaven, a tubulin inhibitor, is the first single agent therapy to show a significant survival advantage in this type of soft tissue sarcoma – a cancer associated with poor outcomes. Just half of people with soft tissue sarcomas are expected to live five years.

The drug also 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.  

Patrick Schöffski, head of the Department of General Medical Oncology, University Hospitals Leuven, Belgium, says: “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.”

“For the first time, people with liposarcoma, a rare and difficult to treat cancer, have an option that can significantly extend their lives. This is the second form of cancer in which eribulin has demonstrated an overall survival cancer benefit, and we remain committed to developing eribulin’s potential for people with cancer, their family and carers,” adds Gary Hendler, president and commercial director, Eisai Global Oncology Business Unit and chairman & chief executive, Eisai EMEA.

The CHMP’s positive opinion follows the US Food and Drug Administration’s approval of the drug in January in the dame indication. Licence was also granted in Japan to extend the indication of eribulin to treat patients with soft tissue sarcomas in February 2016.

Joel Levy

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