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U.S. Food and Drug Administration approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline.
Soft tissue sarcoma is a type of cancer that begins in the soft tissues of your body. Soft tissues connect, support and surround other body structures. The soft tissues include muscle, fat, blood vessels, nerves, tendons and the lining of your joints. Liposarcoma and leiomyosarcoma are specific types of STS that occur in fat cells (liposarcoma) or smooth muscle cells (leiomyosarcoma).
To evaluate the effectiveness and safety of Yondelis, study involved 518 participants with metastatic or recurrent leiomyosarcoma or liposarcoma. Participants were randomly assigned to receive either Yondelis (345 patients) or dacarbazine (173 patients), another chemotherapy drug. Participants who received Yondelis experienced a delay in the growth of their tumor (progression-free survival), which occurred on average about 4.2 months after starting treatment, compared to participants assigned to dacarbazine, whose disease progressed an average of 1.5 months after starting treatment.
The most common side effects among participants who received Yondelis were nausea, fatigue, vomiting, diarrhea, constipation, decreased appetite, shortness of breath (dyspnea), headache, tissue swelling (peripheral edema), a decrease in infection-fighting white blood cells (neutropenia), low blood platelet counts (thrombocytopenia), low red blood cell count (anemia), elevated liver enzymes and decreases in albumin, a protein found in blood. Women who are taking Yondelis should not breastfeed.
Yondelis is marketed by Janssen Products of Raritan, New Jersey.
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