Eisai has received approval from the US Food and Drug Administration (FDA) for Halaven (eribulin mesylate) injections as a treatment for metastatic breast cancer in patients who have had at least two previous chemotherapeutic regimens.
Halaven is a non-taxane, microtubule dynamics inhibitor that is a synthetic analogue of halichondrin B, a product derived from the marine sponge Halichondria okadai.
The approval is based on the results from a Phase III clinical study that showed that the drug increased survived by a median of 2.5 months, compared to a single-agent therapy chosen by each patient’s doctor.
The overall survival of patients receiving Halaven was 13.12 months compared to 10.65 months for those in the treatment of physician’s choice group.
To be eligible for the drug, patients need to have received prior therapy involving, an anthracycline and a taxane, for early or advanced breast cancer.