The company said that 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.
Currently, Halaven is indicated in Europe to treat patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease.
The EC approval 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.
Through the expansion, the drug will now be able to contribute at an earlier stage to patients with metastatic breast cancer in countries of the EU.
The European approval is based on data from two pivotal Phase III trials conducted in over 1,800 patients.
First is the Phase III clinical trial (Study 305: EMBRACE) of Halaven 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.
Second is a Phase III clinical trial (Study 301) of Halaven versus capecitabine in women with locally advanced or metastatic breast cancer who had received prior treatment with an anthracycline and a taxane.