FDA Approves Trabectedin for Metastatic or Unresectable Soft Tissue Sarcoma

The FDA has approved trabectedin (Yondelis) for treatment of unresectable or metastatic soft tissue sarcoma.
The FDA has approved trabectedin (Yondelis) for treatment of unresectable or metastatic soft tissue sarcoma.

The US Food and Drug Administration has approved trabectedin (Yondelis) for the treatment of patients with 2 types of unresectable or metastatic soft tissue sarcoma, liposarcoma and leiomyosarcoma. Trabectedin is approved for patients who have previously received anthracycline-containing chemotherapy.

“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 Yondelis provides a treatment option for advanced or metastatic liposarcoma and leiomyosarcoma.”

Approval is based on a study that found trabectedin improved progression-free survival by 2.7 months compared with dacarbazine in 518 patients with metastatic or recurrent leiomyosarcoma or liposarcoma.

The common adverse events associated with trabectedin treatment were nausea, fatigue, emesis, diarrhea, constipation, reduced appetite, shortness of breath, headache, peripheral edema, neutropenia, thrombocytopenia, anemia, increased liver enzymes, and reduced albumin.

Health care providers should be aware that trabectedin can cause severe and fatal neutropenic sepsis, rhabdomyolysis, hepatotoxicity, extravasation, tissue necrosis, and cardiomyopathy. Women should also be advised of the potential risks to a fetus while receiving trabectedin and should not breastfeed during treatment.


1. FDA approves new therapy for certain types of advanced soft tissue sarcoma [news release]. Bethesda, MD: FDA News Release; October 23, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncPressA/ucm468832.htm. Accessed October 26, 2015.

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