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Halaven®, the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action, belongs 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.

Halaven was first approved as a treatment for breast cancer in the United States in November 2010, and is now approved in more than 55 countries worldwide, including European Union member states, Japan and other Asian countries. In June 2014, Eisai received approval from the European Commission of the indication expansion of Halaven to contribute earlier treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments. Furthermore, the clinical development of Halaven as the treatment of other types of cancer such as soft-tissue sarcoma is also ongoing.

The approval of Halaven in Australia was based on the results of the pivotal Phase Ⅲ EMBRACE study, an open-label, randomized, multi-center, parallel two-arm study designed to compare overall survival (OS) in women treated with Halaven versus a Treatment of Physician's Choice (TPC). In the study, which included 762 participants with metastatic breast cancer who previously had been treated with an anthracycline and a taxane, Halaven indicated extended overall survival (OS) of 2.5 months (OS of 13.1 months versus 10.6 months, respectively; Hazard Ratio (HR) 0.81; p=0.041) when compared to selected, major existing therapies. An updated analysis of OS (not protocol-specified) in the EMBRACE study was also performed at the request of European and U.S. regulatory authorities. These results demonstrated an increase of 2.7 months in OS for Halaven compared with TPC (OS of 13.2 months versus 10.5 months, respectively; HR 0.81; p=0.014). The most common adverse reactions (events with an incidence rate of at least 25%) among patients treated with Halaven were asthenia (fatigue), neutropenia, alopecia (hair loss), peripheral neuropathy (numbness and tingling in arms, legs and/or other parts of the body), nausea and constipation. The most common adverse reaction resulting in discontinuation of treatment with Halaven was peripheral neuropathy (5%).