The U.S. Food and Drug Administration (FDA) approved trabectedin (Yondelis) for the treatment of patients with unresectable or metastatic liposarcoma and leiomyosarcoma who have previously received anthracycline-based 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 was based on findings from a clinical trial in which 518 patients with metastatic or recurrent leiomyosarcoma or liposarcoma were randomly assigned 2:1 to receive trabectedin or dacarbazine.
Results showed that median progression-free survival was 4.2 months in the trabectedin group compared with 1.5 months in the dacarbazine group.
The most common adverse events associated with trabectedin in the study were nausea, vomiting, diarrhea, constipation, decreased appetite, dyspnea, headache, peripheral edema, neutropenia, thrombocytopenia, anemia, elevated liver enzymes, and reduced albumin.
Health care providers should be aware of the risk of severe and fatal neutropenic sepsis, rhabdomyolysis, hepatotoxicity, extravasation, tissue breakdown, and cardiomyopathy.
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Clinicians should also advise women of child-bearing age of potential risks to a developing fetus when taking trabectedin and those with a baby to avoid breastfeeding while receiving trabectedin.
Trabectedin is a synthetically produced anti-tumor agent derived from the sea squirt Ecteinascidia turbinata. The antineoplastic agent binds to the minor groove of DNA, thereby bending the helix to the major groove, which in turn triggers a cascade of events that ultimately disrupts the cell cycle and causes cell death.
- 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 23, 2015.