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.