FDA recently approved (Halaven, Eisai), the first chemotherapy drug to demonstrate survival benefit for liposarcoma that cannot be removed by surgery or is advanced.
FDA recently approved eribulin mesylate (Halaven, Eisai), the first chemotherapy drug to demonstrate survival benefit for liposarcoma that cannot be removed by surgery or is advanced. This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.
“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 in FDA’s Center for Drug Evaluation and Research. “The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug.”
"Although liposarcoma accounts for less than 1% of all malignant tumors, it is a challenging journey for patients, since diagnosis and treatment can be difficult," said Alison Olig, executive director at Sarcoma Alliance. "The approval of Halaven is important for these patients, as it represents a new treatment choice where limited options have existed."
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Halaven was first approved in the United States in 2010 for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic disease. Halaven is the first and only single agent to significantly extend overall survival in the third-line for patients with metastatic breast cancer, according to Eisai.
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 other parts of the body (metastatic), and who had been treated with chemotherapy.
Participants were treated with either Halaven or another chemotherapy drug, dacarbazine, until their disease spread or until they were no longer able to tolerate the side effects of treatment. The median overall survival for patients with liposarcoma receiving Halaven was 15.6 months, compared to 8.4 months for those who received dacarbazine.
"There is an unmet medical need for patients with soft tissue sarcoma whose disease no longer responds to treatment," said George Demetri, MD, professor of medicine at Harvard Medical School and director of the Center for Sarcoma and Bone Oncology at Dana-Farber Cancer Institute. "Halaven has been shown to help patients with advanced liposarcoma live longer, a meaningful result for patients with this rare and hard-to-treat disease."
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, abdominal pain and fever. Halaven may also cause low levels of infection-fighting white blood cells or decreased levels of potassium or calcium.
Serious side effects from treatment with Halaven may include a decrease in white blood cell count, which can increase the risk of serious infections that could lead to death; numbness, tingling or burning in the hands and feet; harm to a developing fetus; as well as changes in heartbeat (QTc prolongation), which may also lead to death.
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