The U.S. Food and Drug Administration has approved Yondelis (trabectedin) for the treatment of patients with the soft tissue sarcomas liposarcoma and leiomyosarcoma that are unresectable or metastatic. The treatment is approved for use in patients who previously received chemotherapy that contained anthracyclines.
Yondelis, marketed by Janssen Products, is a novel, multimodal, synthetically produced antitumor agent that prevents tumor cells from multiplying.
"The treatment of advanced or metastatic soft tissue sarcoma represents a difficult challenge with few effective therapeutic choices available for patients," Richard Pazdur, MD, Director of the FDA's Office of Hematology and Oncology Products, said in a news release. "The approval of Yondelis provides a treatment option for advanced or metastatic liposarcoma and leiomyosarcoma."
The drug was approved after previously receiving priority review status earlier this year (OT 3/10/15 issue).
Effectiveness and safety were demonstrated in a clinical trial of 518 participants with metastatic or recurrent leiomyosarcoma or liposarcoma who received Yondelis or dacarbazine. Progression-free survival for patients receiving Yondelis was 4.2 months on average compared with 1.5 months on average for patients receiving dacarbazine.
The most common side effects for patients receiving Yondelis were nausea, fatigue, vomiting, diarrhea, constipation, decreased appetite, dyspnea, headache, peripheral edema, neutropenia, thrombocytopenia, anemia, elevated liver enzymes, and decreases in albumin.
Yondelis also carries a warning alerting health care providers of the risk of severe and fatal neutropenic sepsis, rhabdomyolysis, hepatoxicity, extravasation, tissue necrosis, and cardiomyopathy.
And patients with known hypersensitivity to trabectedin should not take Yondelis, according to a news release from the manufacturer.
Clinical Quick Facts: Yondelis
Drug: Yondelis (trabectedin)
Approved Indication: Treatment of patients with liposarcoma and leiomyosarcoma that is unresectable or metastatic
Serious Side Effects: Neutropenic sepsis, rhabdomyolysis, hepatoxicity, extravasation, tissue necrosis, and cardiomyopathy
Common Side Effects: Nausea, fatigue, vomiting, diarrhea, constipation, decreased appetite, dyspnea, headache, peripheral edema, neutropenia, thrombocytopenia, anemia, elevated liver enzymes, and decreases in albumin