Source: US Food and Drug Administration
The FDA has now approved Eribulin mesylate injection (Halaven; Eisai, Inc) yesterday for the treatment of metastatic breast cancer. The drug is for patients who have received at least 2 prior chemotherapy regimens for late-stage breast cancer.
Eribulin is a synthetic analog of halichondrin B, a novel microtubule dynamics inhibitor extracted from the marine sponge Halichondria okadia.
A phase 3 study of 762 women with metastatic breast cancer who were heavily pretreated with a median of 4 chemotherapy regimens including an anthracycline and a taxane was conducted in advance of approval. Results showed that eribulin significantly improved overall survival. The 1-year survival rate was 53.9% for eribulin-treated patients and 43.7% for those given other drugs.
“There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies,” said Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, in an agency news release. “Halaven shows a clear survival benefit and is an important new option for women.”
Adverse events most commonly reported the study patients included neutropenia, anemia, leukopenia, alopecia, fatigue, nausea, asthenia, peripheral neuropathy, and constipation.
Some promising news as we head into another holiday season.
~Posted by D.M. Schwadron, Esquire