05 September 2012 | News | By BioSpectrum Bureau
South Korea approves Halaven for breast cancer
Halaven is approved for treatment of locally advanced or metastatic breast cancer patients who have been treated with at least two chemotherapies
Singapore: Eisai's South Korean sales subsidiary 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 is the anticancer agent to be discovered and developed by Eisai in-house, and is the only single-agent chemotherapy to demonstrate a statistically significant overall survival 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.
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.
South Korea is the third largest market in Asia after Japan and China, and constitutes the 12th largest pharmaceutical market in the world. Eisai Korea has already established a presence in the area of integrative oncology with the launch of the anticancer agent Symbenda (bendamustine hydrochloride) in October 2011 for the treatment of chronic lymphocytic leukemia and multiple myeloma.
A press release issued by the company said it will continue to step up its efforts in the field of oncology with the addition of Halaven to its integrative oncology product portfolio as it seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, cancer patients and their families.