Drug sanctioned for liposarcoma or leiomyosarcoma
FRIDAY, Oct. 23, 2015 (HealthDay News) — The chemotherapy drug Yondelis (trabectedin) has been approved by the U.S. Food and Drug Administration to treat certain advanced or unresectable soft-tissue sarcomas (STS).
Yondelis is approved for patients with two forms of STS — liposarcoma or leiomyosarcoma — who have had previous treatment with chemotherapy containing anthracycline, the FDA said.
Yondelis was evaluated in clinical studies involving 518 patients. Patients who took Yondelis had average progression-free survival of 4.2 months, compared to an average of 1.5 months among those who took dacarbazine, the agency said.
The most common side effects of Yondelis include nausea, fatigue, vomiting, diarrhea, constipation, loss of appetite, dyspnea, headache, and peripheral edema. The drug’s label warns of the possibility of more serious side effects, including neutropenic sepsis, rhabdomyolysis, hepatotoxicity, leakage around the vein or catheter, tissue necrosis, and cardiomyopathy. It also warns women of childbearing age of potential harm to a developing fetus, and against breastfeeding while on the drug.
Yondelis is marketed by Janssen Products, based in Raritan, N.J.
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