Background and objectives: Eribulin is a cytostatic drug. It has been approved for women with advanced/metastatic breast cancer by FDA in 2010 and by EMA 2011. It is indicated, when first and second line therapeutics have no more effect.

Method: A literature systematic literature search was performed and the evidence was summarized. The quality of the report was controlled by internal and external peer review.

Results: One phase III and two phase-II studies provide the basis for assessing the benefit-harm balance of Eribulin. The Eribulin arm in the phase III study shows a median survival of 13.1 (CI: 11.8 – 14.3) versus 10.6 (CI: 9.3 – 12.5) month in the control group, indicating a clinically significant survival benefit. In contrast the toxicity was higher in the Eribulin arm (particularly for neutropenia, leucopenia and peripheral neutropathia). The study has limitations in the study design and no assessment of the quality of life has been performed.

Commentary: Eribulin is a valuable option in a patient group with limited therapeutic options. Due to a lack of information regarding quality of live the net benefit for patients remain partly unclear.