The U.S. Food and Drug Administration has accepted Halaven (Eribulin Mesylate), a kind of chemotherapy, for the therapy of liposarcoma (a particular kind of soft tissue sarcoma) that can’t be removed by surgery (unresectable) or is advanced (metastatic). This therapy is approved for sufferers who obtained prior chemotherapy that contained an anthracycline drug.
Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said,
“Halaven is the initial drug accepted for sufferers with liposarcoma that has proven an enhancement in survival time.” The clinical study data the FDA analyzed signifies that Halaven improved overall survival by around seven months, providing sufferers a clinically significant drug.”
Soft tissue sarcoma (STS) is a condition in which cancer cells form in the soft tissues, which includes the muscles, tendons, fat, blood vessels, lymph vessels, nerves and tissues close to joints. Liposarcoma is a particular kind of STS that takes place in fat cells. STS can form at almost any place in the body, but is most frequent in the head, neck, arms, legs, trunk and abdomen. In 2014, an approximated 12,000 cases of STS were clinically diagnosed in the United States, as reported to the National Cancer Institute.
The effectiveness and safety of Halaven were assessed in 143 clinical trial individuals with advanced liposarcoma that was unresectable or had propagated close to lymph nodes (locally advanced) or other parts of the body (metastatic), and who had been treated with chemotherapy. Individuals were treated with either Halaven or another chemotherapy drug known as dacarbazine till their disease spread or till they were no longer capable to tolerate the side effects of therapy. The study was developed to evaluate the duration of time from the start of therapy till a patient’s death (overall survival). The median overall survival for sufferers with liposarcoma receiving Halaven was 15.6 months in comparison to 8.4 months for those who obtained dacarbazine.
The most common side effects among individuals administered Halaven were alopecia, constipation, fatigue, nausea, peripheral neuropathy and pyrexia. Halaven may also lead to low levels of infection-fighting white blood cells (neutropenia) or reduced levels of potassium or calcium.
Serious side effects from therapy with Halaven may be a reduction in white blood cell count, which can raise the risk of severe infections that could result in death; numb feeling, tingling or burning in the hands and feet (neuropathy); damage to a developing fetus; along with modifications in heartbeat (QTc prolongation), that may also result in death.
The FDA provided the Halaven application a priority review status, designed to facilitate and speed up the development and evaluation of specific drugs in light of their potential to benefit sufferers with severe or life-threatening problems. Halaven also obtained orphan drug status, which offers benefits such as tax credits, user fee waivers, and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.