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FDA Approves Trabectedin for Advanced Liposarcoma and Leiomyosarcoma

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The U.S. Food and Drug Administration today approved the chemotherapy drug trabectedin (Yondelis) for the treatment of specific soft-tissue sarcomas—liposarcoma and leiomyosarcoma—that are unresectable or metastatic. This treatment is approved for patients who previously received chemotherapy that contained anthracycline.

“The treatment of advanced or metastatic soft tissue sarcoma represents a difficult challenge with few effective therapeutic choices available for patients,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of [trabectedin] provides a treatment option for advanced or metastatic liposarcoma and leiomyosarcoma.”

Clinical Trial Results

The effectiveness and safety of trabectedin were demonstrated in 518 clinical trial participants with metastatic or recurrent leiomyosarcoma or liposarcoma. Participants were randomly assigned to receive either trabectedin (n = 345) or dacarbazine (n = 173), another chemotherapy drug. Participants who received trabectedin experienced a 4.2-month improvement in median progression-free survival, 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 trabectedin were nausea, fatigue, vomiting, diarrhea, constipation, decreased appetite, dyspnea, headache, peripheral edema, neutropenia, thrombocytopenia, anemia, elevated liver enzymes, and decreases in albumin.

Trabectedin carries a warning alerting health-care providers of the risk of neutropenic sepsis, rhabdomyolysis, hepatotoxicity, extravasation, tissue necrosis, and cardiomyopathy. Patients with known hypersensitivity to trabectedin should not take the drug.

Health-care providers are also encouraged to advise women of potential risks to a developing fetus when taking trabectedin. Women who are taking trabectedin should not breastfeed.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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