Eisai gets South Korean approval for breast cancer drug Halaven

The South Korean sales subsidiary of Japanese drug major Eisai (TYO: 4523) has received approval from the regulatory authorities in South Korea to market the anticancer agent Halaven (eribulin mesylate) for the treatment of locally advanced or metastatic breast cancer patients who previously have been treated with at least two prior chemotherapies, including an anthracycline and a taxane.

Halaven, discovered and developed by Eisai in-house, is the only single-agent chemotherapy to demonstrate a statistically significant overall survival (OS) benefit in Phase III studies (EMBRACE study) conducted in pretreated advanced and metastatic breast cancer patients. Including South Korea, Halaven is currently approved in 38 countries worldwide, and generated first-quarter fiscal 2013 (April-June 2012) of 5.5 billion yen ($70.2 million). The drug’s first approval came in the USA in November 2010.

Breast cancer is the second most commonly diagnosed type of cancer in the world, with an estimated 15,000 people being newly diagnosed with the disease in South Korea each year. This latest approval of Halaven will now enable late-stage metastatic breast cancer patients with significant unmet medical needs across South Korea to access this innovative therapeutic agent.