Eisai Co., Ltd. has submitted applications to regulatory authorities in Japan, the United States, and Europe seeking an additional indication for its in-house developed anticancer agent Halaven (eribulin mesylate) as a treatment for soft tissue sarcoma. Halaven has been designated as an orphan drug for soft-tissue sarcoma in the United States and Japan.

Halaven was first approved as a treatment for breast cancer in the United States in November 2010 and is now approved in nearly 60 countries worldwide, including Japan and countries in the Americas, Europe, and Asia. In Japan, Halaven has been approved to treat inoperable or recurrent breast cancer and was launched in the country in July 2011. Halaven has also been approved in countries in Europe and Asia indicated as a treatment for patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease.

Halaven, a halichondrin class microtubule dynamics inhibitor belonging to a class of antineoplastic agents, the halichondrins, which are natural products isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequestering tubulin into nonproductive aggregates.

Source: Eisai