European Medicines Agency Adopted a Change to an Indication for Eribulin

It is indicated for patients with locally-advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease

On 22 May 2014, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product eribulin (Halaven).

The marketing authorisation holder for this medicinal product is Eisai Europe Ltd. They may request a re-examination of the CHMP opinion, provided that they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The CHMP adopted a change to an indication as follows:

"Halaven is indicated for the 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."

Detailed conditions for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.