On May 6, 2016, Eisai Co. , Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that its European regional headquarters Eisai Europe Ltd. (Location: U. K. )has received from the European Commission approval foranti cancer agent Halaven(eribulin mesylate)for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy(unless unsuitable)for advanced or metastatic disease (Press release, Eisai, MAY 6, 2016, View Source [SID:1234511989]).

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Halaven is the first and only single agent to demonstrate a statistically significant overall survival (OS) benefit in a Phase III trial in patients with advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma). Following approval for use in the treatment of metastatic breast cancer, this marks the second indication for which Halaven has received approval based on an extension ofOS. The approval was based on the results of a Phase III study (Study 309)1comparing the efficacy and safety of Halaven versus dacarbazine in 452 patients (aged 18 or over) with locally advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies which must have included an anthracycline and at least one other additional regimen. Halaven demonstrated a statistically significant extension in the study’s primary endpoint of OS over the comparator treatment dacarbazine(Halaven median OS: 13. 5 months vs dacarbazine median OS: 11. 5 months; Hazard Ratio (HR) 0. 77[95% CI=0. 62-0. 95], p=0. 0169). For patients with liposarcoma, Halaven demonstrated a significant improvement in OS over dacarbazine (Halaven,median OS: 15. 6months vs dacarbazine, median OS: 8. 4months;HR 0. 51[95% CI=0. 35-0. 75]). In this study, the most common treatment-emergent adverse events (incidence greater than or equal to 25%) in patients treated with Halaven were fatigue, neutropenia, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia, which was consistent with the known side-effect profile of Halaven. Halaven is a halichondrin class microtubule dynamics inhibitor with a distinct binding profile. Recent non-clinical studie showed that Halaven is associated with increased vascular perfusion and permeability in tumor cores. 2Halavenpromotes the epithelial state and decreases the capacity of breast cancer cells to migrate. 3Halaven is currently approved for use in the treatment of breast cancer inapproximately60 countries including Japan and countries in Europe ,the Americas and Asia. Halaven was approved in the United States for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen in January 2016, and was approved in Japan for the treatment of soft tissue sarcoma in February 2016. Soft tissue sarcoma is a collective term for a diverse group of malignant tumors that occur throughout the soft tissue(fat, muscle, nerves, fibrous tissues and blood vessels). Approximately29,000 patients in Europe are diagnosed with soft tissue sarcoma each year or about1% of all cancers diagnosed in Europe. Liposarcoma is one of the most common forms of soft tissue sarcoma. As outcomes are poor for patients with advanced disease, it remains a disease with significant unmet medical need.