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The China Food and Drug Administration (CFDA) has accepted for review a New Drug Application (NDA) submitted for Eisai's in-house developed anticancer agent eribulin mesylate (eribulin, product name: Halaven) for use in the treatment of patients with locally advanced or metastatic breast cancer in China.
The NDA was based on Study 304, a multicenter, open-label, randomized, parallel group phase III clinical study conducted in China to evaluate the efficacy and safety of eribulin and vinorelbine in 530 female subjects with locally recurrent or metastatic breast cancer, previously treated with at least two and a maximum of five prior chemotherapy regimens, including an anthracycline and a taxane. In this study, the primary objective was to assess progression-free survival (PFS) in both treatment groups. From the results for the study, eribulin demonstrated a statistically significant extension in PFS over the comparator treatment vinorelbine.
Halaven is a halichondrin class microtubule dynamics inhibitor with a distinct binding profile. Recent non-clinical studies showed that Halaven is associated with increased vascular perfusion and permeability in tumor cores. Halaven promotes the epithelial state and decreases the capacity of breast cancer cells to migrate. First approved in the United States for use in the treatment of breast cancer in November 2010, Halaven is currently approved in over 60 countries worldwide, including Japan and countries in Europe, the Americas and Asia. Furthermore, Halaven has been designated as an orphan drug for soft tissue sarcoma in the United States and Japan.
