(RxWiki News) This week, the US Food and Drug Administration (FDA) approved Eisai Inc.'s drug derived from sea sponge for a rare type of soft tissue cancer.
The drug, eribulin mesylate (brand name Halaven), was approved for liposarcoma patients who have already received chemotherapy that contained an anthracycline drug, and whose cancer cannot be removed by surgery or is advanced. Halaven was approved in 2010 for advanced breast cancer.
"Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products at the FDA’s Center for Drug Evaluation and Research, in a press release. "The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug."
Soft tissue sarcoma (STS) is a type of cancer that forms in the body's soft tissues, such as the muscles, tendons, fat and nerves, among other areas. Liposarcoma is a type of STS that forms in the fat cells.
In 2014, an estimated 12,000 cases of STS were diagnosed in the US alone, according to the National Cancer Institute.
The safety of Halaven was evaluated in 143 patients with advanced liposarcoma. These patients were treated either with Halaven or another chemotherapy drug called dacarbazine until their cancer spread or they were no longer able to tolerate treatment.
The average overall survival for patients on Halaven was 15.6 months compared to 8.4 months for those on dacarbazine.
The most common side effects of Halaven were fatigue, nausea, hair loss, constipation, weakness or numbness in the hands and feet, abdominal pain and fever. Serious side effects include low white blood cell count; numbness, tingling or burning in the hands and feet; harm to a developing fetus; and heartbeat changes.