Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma that cannot be removed by surgery (unresectable) or is advanced (metastatic) has just been approved by the FDA for patients who received prior chemotherapy that contained an anthracycline drug.
“It is the first treatment to demonstrate an improvement in survival time, offering patients an additional 7-months of survival time,” noted Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Liposarcoma is a specific type of soft tissue sarcoma that occurs in fat cells as opposed to other forms of STS in which cancer cells form in areas such as the muscles, tendons, blood vessels, lymph vessels, nerves and tissues around joints. While soft tissue sarcoma can develop almost anywhere in the body, it is most common in the head, neck, arms, legs, trunk and abdomen. According to the National Cancer Institute, there were an estimated 12,000 cases of the disease were diagnosed in the United States in 2014.
The efficacy and safety of Halaven were evaluated in 143 clinical trial participants with advanced liposarcoma that was unresectable or had spread to nearby lymph nodes (locally advanced) or metastatisized, and who had been treated with chemotherapy. Participants were treated with either Halaven or another chemotherapy drug called dacarbazine until their disease spread or until they were no longer able to tolerate the side effects of treatment. The study was designed to measure the length of time from the start of treatment until a patient’s death (overall survival).The median overall survival for patients with liposarcoma receiving Halaven was 15.6 months compared to 8.4 months for those who received dacarbazine.
The most common side effects among participants treated with Halaven were fatigue, nausea, hair loss, constipation, certain nerve damage causing weakness or numbness in the hands and feet (peripheral neuropathy), abdominal pain and fever. It was also found that Halaven might also cause low levels of infection-fighting white blood cells (neutropenia) or decreased levels of potassium or calcium, as well as neuropathy in hands and feet, and serious changes in heartbeat (QTc prolongation), that may also lead to death, not to mention severe damage to fetuses in pregnant women.