Photo by D. Sharon Pruitt

The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. This year, an estimated 207,090 women will be diagnosed with breast cancer, while 39,840 women will die from the disease.

Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.

Halaven’s safety and effectiveness were established in a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. Patients were randomly assigned to receive treatment with either Halaven or a different single agent therapy chosen by their oncologist.

The study was designed to measure the length of time from when this treatment started until a patient’s death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy.

“There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Halaven shows a clear survival benefit and is an important new option for women.”

The most common side effects reported by women treated with Halaven include 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.

Other FDA-approved therapies used to treat late-stage, refractory breast cancer include Xeloda (capecitabine) for patients with breast cancer resistant to paclitaxel and anthracycline-containing chemotherapy; Ixempra (ixabepilone) for patients with late-stage disease after failure of an anthracycline, taxane and Xeloda; and Ixempra plus Xeloda for patients with late-stage disease after failure of anthracycline- and taxane-based chemotherapy.

Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.

“Our hearts go out to the family and friends of people lost in this tragic event. In the hours after the floodwaters receded, I committed to getting to the bottom of what happened the night of June 11, not only so that we have all the facts about that night, but also to ensure that treasured locations like this one remain available to the public and that they can be enjoyed safely,” said Vilsack. “This report provides valuable information about how we can achieve these goals and prevent similar tragedies in the future, and we will be aggressively moving forward with improved visitor safety actions across the country in the weeks and months ahead.”

Vilsack called for the report following a tour he took of the devastated area with Arkansas officials and Forest Service Chief Tom Tidwell only hours after the floodwaters had receded. The visitor safety report commits the Forest Service to increase its accountability, oversight, and monitoring of public safety issues nationwide. The agency will develop an action plan responsive to the safety report by November 30, 2010.

Based on the Forest Service safety report, the following national actions are being taken:

• The agency will implement a comprehensive safety communication strategy to ensure visitors have information needed to make decisions about their recreation activities.
• Individual facilities will improve their emergency response and evacuation plans, including training exercises and post-incident actions.
• Training on visitor safety for employees and volunteers will be expanded.

“The best way to honor the victims is to redouble our efforts to provide the safest facilities possible in Arkansas and across the country,” said Tom Tidwell, Chief of the Forest Service. “Because of this tragedy, we initiated actions nationally to improve communication of safety messages to visitors, to increase training our own employees regarding visitor safety, and to evaluate early warning systems and their applicability in the agency.”

The full report can be found at: Recreation-Safety-Report-10-18-10.pdf

The Forest Service report builds upon and responds to information contained in another report done by a USDA review team that looked at the events at Albert Pike campground on June 11th. This report is available at: Albert_Pike_Review_Team_Report_September_24_2010.pdf

A severe storm that struck the evening of June 11. The Little Missouri River Rose from a pre-storm level of just less than four feet deep to an estimated depth of over 23 feet, and sent a wall of water through the campground at 3 a.m. while campers were asleep. Cell phone coverage in the Albert Pike Campground, a favorite vacation destination for generations of Arkansans, was spotty at best.

The mission of the USDA Forest Service is to sustain the health, diversity, and productivity of the Nation’s forests and grasslands to meet the needs of present and future generations. The Agency manages 193 million acres of public land, provides assistance to State and private landowners, and maintains the largest forestry research organization in the world.

USDA is an equal opportunity provider, employer and lender. To file a complaint of discrimination, write: USDA, Director, Office of Civil Rights, 1400 Independence Ave., S.W., Washington, D.C. 20250-9410 or call (800) 795-3272 (voice) or (202-720-6382 (TDD).