According to a U.S. Food and Drug Administration (FDA) press release, the agency has just approved Halaven (eribulin mesylate) – a specific type of chemotherapy for the treatment of liposarcoma (a soft tissue sarcoma) that is in an advanced state (metastatic) or cannot be removed through surgery (unresectable). Furthermore, the chemotherapy is indicated for patients who received previous treatment containing an anthracycline drug.
Liposarcoma is a particular kind of soft tissue sarcoma (STS) – a disease where cancer cells group in the soft tissues, such as tissues around joints, nerves, lymph vessels, blood vessels, fat, tendons or muscles – which occurs primarily in fat cells. In 2014, approximately 12,000 cases of STS are estimated to have been diagnosed in the U.S. alone, according to the National Cancer Institute.
Halaven was evaluated for its safety and efficacy in 143 clinical trial participants with an advanced form of liposarcoma that had spread to surrounding lymph nodes (locally advanced), that was unresectable or that was metastatic and who had all been treated with chemotherapy. The trial was designed to measure the patients’ overall survival rate by being administered either Halaven or another chemo drug, dacarbazine. The median overall survival for liposarcoma patients that were given Halaven was significantly superior to dacarbazine, with 15.6 months over 8.4 months, respectively.
“Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time,” commented the Director of the FDA’s Office of Hematology and Oncology Products, Richard Pazdur, M.D. “The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug.”
Eisai, the New Jersey-based company that is marketing Halaven claims the most common side effects reported by trial subjects were abdominal pain, fever, nerve damage leading to numbness in the feet and hands (peripheral neuropathy) or weakness, constipation, hair loss (alopecia), nausea and fatigue. Additionally, the trials suggest the drug may also decrease levels of calcium or potassium and even low levels of infection-fighting white blood cells (neutropenia) – the latter might be serious as it might increase the risk of infections, changes in heartbeat or harm a developing fetus. Halaven was previously granted priority review status by the FDA followed by the reception of an orphan drug designation.