Eisai Europe seeks EMA approval of eribulin mesylate for locally advanced or metastatic breast cancer

Eisai Europe Ltd. (TOKYO:4523) today announced that it has submitted a marketing authorization application to the European Medicines Agency (EMA) for approval of eribulin mesylate, also known as 'E7389', for the treatment of locally advanced or metastatic breast cancer in Europe. Eribulin mesylate, a non-taxane microtubule dynamics inhibitor, is an investigational chemical compound discovered and developed by Eisai. Regulatory applications for eribulin mesylate have also been submitted in the United States and Japan.

“giving first thought to patients and their families and to increasing the benefits health care provides”

The submission is based primarily on data from a pivotal, global Phase III study known as "EMBRACE" (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389), which was an open-label, randomized, parallel two-arm, multi-center study with 762 women with locally recurrent or metastatic breast cancer previously treated with at least two chemotherapy regimens, including an anthracycline and a taxane. Study results showed that it met its primary endpoint of demonstrating a statistically significant improvement in overall survival in eribulin mesylate treated patients compared with treatment of physician's choice.

The patients were treated either with eribulin (administered intravenously over two to five minutes on days 1 and 8 every 21 days) or with treatment of physician's choice. Treatment of physician's choice was defined as any single agent chemotherapy, hormonal treatment or biological therapy approved for the treatment of cancer; or palliative treatment or radiotherapy administered according to local practice.

EMBRACE is the first global Phase III study to compare a new agent, eribulin mesylate, to real-world choices in heavily pre-treated patients with metastatic breast cancer. The Physician's Choice (TPC) arm of the study was included following recognition of the heterogeneous nature of the patient population, as well as the need for clinicians to tailor treatment regimes for individual patients.

Eribulin mesylate has a distinct mechanism of action that suppresses microtubule dynamics without affecting microtubule shortening parameters. It is delivered as an IV infusion with an administration time of between two and five minutes on days one and eight of a 21-day cycle. The infusion time for eribulin mesylate is relatively short when compared to taxanes, such as docetaxel which has an infusion time of one hour (every three weeks). In addition, treatment with eribulin mesylate did not require any pre-medication.

The most frequent adverse events (AEs) reported by patients treated with eribulin mesylate were asthenia (fatigue), neutropenia (low white blood cell count), alopecia (hair loss), nausea and peripheral neuropathy (numbness, tingling in different parts of the body). Patients with pre-existing neuropathy were enrolled into the trial.