Eribulin (Halaven): A New Drug For Refractory, Metastatic Breast Cancer

Eribulin (Halaven) was approved as a new molecular entity for breast cancer by the U.S. Food and Drug Administration in November 2010. This drug is a cyclic organic molecule, and it has a molecular weight of 729.9. Its structure as an organic molecule and its low molecular weight distinguish it from new biological entities approved as cancer drugs by the FDA. These new biological entities are often monoclonal antibodies, large protein molecules with molecular weights typically in excess of 100,000. Eribulin is intended for use in patients who have refractory, metastatic breast cancer, meaning their cancer has not responded to treatment with standard chemotherapy regimens and has spread from the breast to other tissue.

In a report published in the March 12, 2011, issue of "The Lancet," researchers described the results of a phase 3 clinical study of eribulin in 762 women with metastatic breast cancer. All of the patients in the study had previously received between two and five treatments with various cancer chemotherapy regimens. The patients were divided into two groups: one group of 508 received eribulin as an intravenous infusion on days 1 and 8 of a 21-day cycle and the other group of 254 received a treatment of the physician's choice. The results of the trial showed that women who received eribulin survived for an average of 13.1 months, while those who got the physician's choice treatment survived for an average of 10.6 months.

The physicians and other researchers who carried out this study believe that it puts to rest the notion that it is unreasonable to expect improvements in survival in patients with refractory, metastatic breast cancer.

In the phase 3 study reported in "The Lancet," the most common side effects of eribulin therapy were loss of energy and strength (asthenia), fatigue and neutropenia. Neutropenia is a condition characterized by an abnormally low number of neutrophils in the blood. Neutrophils are a type of white blood cells that are part of the immune system and function to fight off invading organisms. Patients in this phase 3 study cited peripheral neuropathy most frequently as a reason for discontinuing therapy with eribulin. Peripheral neuropathy refers to damage to nerves of the extremities, particularly the hands and feet. Symptoms of peripheral neuropathy include a tingling sensation, pain and numbness in the hands and feet.

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