Eisai's Eribulin (Halaven(R)) Receives Swissmedic Approval for use in Locally Advanced and Metastatic Breast Cancer

Eribulin (Halaven(R)) is today approved for use in Switzerland by Swissmedic, the Swiss Agency for Therapeutic Products, as a monotherapy treatment of patients with locally advanced and metastatic breast carcinoma with progression after prior therapy with an anthracycline, a taxane and capecitabine. Breast cancer is the second most commonly diagnosed cancer worldwide and there are about 1.3 million new cases of the disease annually. More than 5,000 Swiss women have the disease and approximately 1,400 are likely to die annually.
Eisai submitted a New Drug Application based on the results from a Phase II study (Study 211) of eribulin in order to deliver the medicine to patients as quickly as possible. The approval was based upon the Phase II and Phase III data.
Dr Matti Aapro, Dean of the Multidisciplinary Oncology Institute, Genolier, Switzerland commented, "This is a significant medical advance in a setting where there is currently no recognised standard of care. Until now we have not had robust clinical trial data to guide our treatment of these patients so I welcome today's news of the Swissmedic approval for use of eribulin which will allow patients in Switzerland to gain access to this important new treatment. The EMBRACE study demonstrates that eribulin is an effective and relatively well-tolerated treatment, as well as the first single agent chemotherapy to provide statistically significant overall survival improvements for patients with metastatic breast cancer previously treated with an anthracycline and a taxane."
The Swissmedic approval means that patients in Switzerland will soon be able to benefit from this innovative treatment. Eribulin is approved for treatment for women with locally advanced or metastatic breast cancer who have progressed after previous treatment with an anthracycline, a taxane and capecitabine.
Eribulin is the first single-agent chemotherapy to demonstrate a significant overall survival benefit in patients with advanced breast cancer in the population studied within EMBRACE. The Swissmedic approval means that patients in Switzerland will soon be able to benefit from this innovative treatment.
Eribulin was approved in the USA in November 2010, in Singapore in February 2011, in Europe in March 2011 and Japan in April 2011, and has already been launched in USA, UK, Nordics and Japan.
Eisai's commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, biologic and supportive care agents for cancer across multiple indications. Through these efforts, Eisai will make further contributions to addressing the diversified needs of and increasing the benefits provided to patients and their families as well as healthcare professionals as it seeks to fulfill its human health care (hhc) mission.