Eribulin for soft tissue sarcoma filed in US, EU and Japan- Eisai

Eisai announced that regulatory applications were submitted simultaneously in the United States, European Union and Japan (to the FDA, EMA and MHLW, respectively) for eribulin, for the treatment of patients with inoperable soft tissue sarcoma (STS) who have received prior chemotherapy for advanced or metastatic disease.

These regulatory filings are based on data from a pivotal global Phase III clinical trial (Study 309), which met its primary endpoint evaluating overall survival in patients previously treated for soft tissue sarcoma. Study 309 is the first and only study to meet an overall survival endpoint at this stage of the disease. These data were presented at an oral session at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2015.

Comment: Eribulin is approved for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic disease, and whose prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.