In fiscal year 2011, FDA approved 7 “new molecular entities” (NMEs) in oncology.
7. Halaven (eribulin mesylate) for metastatic breast cancer.
Importance: Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. This year, an estimated 230,480 women will be diagnosed with breast cancer, while 39,520 women will die from the disease. Halaven was approved to treat breast cancer patients whose cancer has metastasized (spread) and who have already been treated with at least two other chemotherapeutic regimens for metastatic breast cancer. Halaven is the first single agent to show an overall improvement in survival in these patients. The approval of this drug is important because of the limited options currently available to women with aggressive forms of late-stage breast cancer.
Actions to speed drug testing and review: Halaven was given a Fast Track designation for its potential to treat advanced relapsed or refractory breast cancer. Halaven’s safety and effectiveness were established in a single trial in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. FDA did not require the sponsor to replicate the study findings in a second trial. Patients were randomly assigned to receive treatment with either Halaven or a different single agent therapy chosen by their oncologist. The trial was designed to measure the length of time from when this treatment started until a patient’s death (overall survival). On average, patients treated with Halaven lived 2.5 months longer than those treated with an alternate therapy. Halaven was reviewed under the FDA’s priority review program which provides for an expedited six-month review of drugs.
Safety issues: FDA concluded that the benefits of Halaven outweighed the risk of reported side effects, including a decrease in infection-fighting white blood cells (neutropenia), anemia, a decrease in the number of white blood cells (leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve damage (peripheral neuropathy), and constipation.
Source: FDA - FY 2011 Innovative Drug Approvals