Halaven (eribulin mesylate) has been approved by the U.S. Food and Drug Administration as the first chemotherapy drug shown to improve survival in people with advanced liposarcoma, a type of soft tissue sarcoma (cancer).
The drug is sanctioned for people who have received prior chemotherapy with a drug that contained anthracycline, the agency said Thursday in a news release.
Soft tissue sarcoma occurs when cancer invades soft tissues, such as muscles, tendons, fat, blood vessels, lymph nodes, nerves and tissues that surround joints, the FDA said. Liposarcoma specifically affects fat, most often of the head, neck, arms, legs, trunk or abdomen.
Halaven was evaluated in clinical studies involving more than 140 people with liposarcoma that had spread (metastatic) or couldn’t be removed surgically. Average survival among people who took Halaven was 15.6 months, compared to 8.4 months among those who took another chemotherapy drug, dacarbazine.
The most common side effects of Halaven included fatigue, nausea, hair loss, constipation, nerve damage, abdominal pain and fever. Other adverse reactions included a drop in germ-fighting white blood cells and decreased levels of the minerals potassium or calcium.
More serious side effects included deadly infection, nerve damage, harm to a pregnant woman’s fetus, and dangerous heartbeat abnormalities, the FDA said.
Halaven is marketed by Woodcliff Lake, N.J.-based Eisai Inc.
Visit the FDA to learn more.
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