The U.S. Food and Drug Administration approved on Thursday a chemotherapy treatment for liposarcoma. Halaven is ideal for patients whose soft tissue sarcoma cannot be surgically removed or has advanced.
Approved for patients who have been administered chemotherapy containing an anthracycline drug, Halaven is the first to be approved that has shown improvement in survival time, said Dr. Richard Pazdur from the FDA's Office of Hematology and Oncology Products.
To test the safety and efficacy of Halaven, 143 patients with advanced liposarcoma were given either the medication or dacarbazine, another chemotherapy drug. The clinical trial continued until the participants could no longer tolerate their treatment's side effects or their disease spread. According to results, the average overall survival recorded was 15.6 months for those given Halaven, and 8.4 months the group administered dacarbazine.
The most commonly reported side effects for Halaven included constipation, hair loss, nausea, fatigue, numbness or weakness in the feet and hands caused by nerve damage, fever and abdominal pain. The medication also caused white blood cell, calcium and potassium levels in the body to drop.
Adverse side effects, on the other hand, include low counts of white blood cells that can increase risks of deadly infections; burning or tingling in the feet and hands; heartbeat changes; and harm to developing fetus.
To speed up the drug's progress, Halaven was granted priority review status. It was also awarded orphan drug designation to offer incentives like tax credits, waived user fees and exclusivity eligibility to encourage drug development addressing rate diseases.
Marketed by Eisai, Halaven is sourced from the Halichondria okadai, a marine sponge. It was first approved as treatment for advanced breast cancer in 2010.
Soft tissue sarcoma is a disease where cancer cells develop in soft tissues like blood vessels, muscles, fat, tendons, muscles and nerves. Liposarcoma in particular occurs in the body's fat cells. Soft tissue cancer can form nearly anywhere in the body, but has been observed mostly to occur in the abdomen, trunk, legs, arms, neck and head.
According to the National Cancer Institute, about 12,000 new cases of soft tissue sarcoma were diagnosed in the U.S. in 2014.
Photo: National Institutes of Health | Flickr
