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Eisai has announced that it has received approval from the European Commission ( EC ) of the indication expansion of Halaven ( Eribulin mesylate ) to contribute to earlier treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease.
Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.

Halaven is currently indicated in Europe for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.
The approval received from the European Commission is for the expansion of the current indication, which was limited to patients who had previously received at least two chemotherapeutic regimens, to include patients with metastatic breast cancer who have had less prior treatment.

The approval is based on evidence from two pivotal phase III studies, including the Phase III clinical study ( Study 305: EMBRACE ) of Eribulin versus treatment of physician's choice ( TPC ) in patients with locally advanced or metastatic breast cancer who had previously received at least two to five prior chemotherapeutic regimens including treatments with an anthracycline and a taxane, and a phase III clinical study ( Study 301 ) of Eribulin versus Capecitabine in women with locally advanced or metastatic breast cancer who had received prior treatment with an anthracycline and a taxane.
These studies involved more than 1,800 patients, making this one of the largest data sets in metastatic breast cancer.

Over 300,000 women are diagnosed with breast cancer in Europe every year, of whom about one third subsequently develop metastatic disease. ( Xagena )

Source: Eisai, 2014

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