CHINA FOOD AND DRUG ADMINISTRATION ACCEPTS NDA FOR ANTICANCER AGENT HALAVEN®

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that 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.
In addition, the most common adverse events observed in the eribulin group were neutropenia, anaemia, pyrexia, and fatigue/asthenia, which was consistent with the known side-effect profile of eribulin.

The number of women diagnosed with breast cancer in China has been increasing in recent years,¹ with an estimated 272,400 new cases of invasive breast cancer and 70,700 related deaths in 2015.² Breast cancer is now the most frequently diagnosed cancer in Chinese women.¹

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.³ Halaven promotes the epithelial state and decreases the capacity of breast cancer cells to migrate.⁴ 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.

Eisai positions oncology as a key therapeutic area, and is aiming to discovery revolutionary new medicines with the potential to cure cancer. Eisai remains committed to maximizing the clinical value as well as exploring the potential clinical benefits of Halaven as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers in China and around the world.

Conducted in China, Study 304 was a multicenter, open-label, randomized, parallel group Phase Ⅲ clinical study 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. Patients received either eribulin (1.4 mg/m² administered intravenously on Day 1 and Day 8) or vinorelbine (25 mg/m² administered intravenously on Day 1, Day 8 and Day 15) every 21 days until disease progression.
From the results for the study, eribulin demonstrated a statistically significant extension in the study's primary endpoint of progression-free survival (PFS) over the comparator treatment vinorelbine. The study's secondary endpoints were overall survival (OS) and objective response rate (ORR).
The most common adverse events observed in the eribulin arm were neutropenia, anaemia, pyrexia, and fatigue/asthenia, which was consistent with the known side-effect profile of eribulin.
Detailed results of the study will be presented at an upcoming academic conference.