Wednesday, 05 August 2020

Eisai gets approval for Halaven in Australia

10 September 2012 | Regulatory | By BioSpectrum Bureau

The Australian Department of Health and Aging has approved marketing of Halaven in the country

The Australian Department of Health and Aging has approved marketing of Halaven in the country

Singapore: Eisai Australia, a subsidiary of the Japanese firm Eisai, has received approval from the Australian Department of Health and Aging to market its anticancer agent Halaven (eribulin mesylate) for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.

Halaven is the first anticancer agent to be discovered and developed by Eisai in-house, and was recently granted approval in South Korea. Including Australia, Halaven is currently approved in 39 countries worldwide.

In Australia, breast cancer affects an estimated 150,000 people, with approximately 15,000 new cases of the disease being diagnosed each year. This latest approval of Halaven will now enable late-stage metastatic breast cancer patients with significant unmet medical needs across Australia to access this innovative therapeutic agent.

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