FDA approved Yondelis (trabectedin) for the treatment of liposarcoma and leiomyosarcoma that cannot be removed by surgery or is metastatic. This treatment is approved for patients who previously received chemotherapy that contained anthracycline.
The effectiveness of Yondelis, marketed by Janssen Products, was demonstrated in 518 clinical trial 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, headache, tissue swelling, a decrease in infection-fighting white blood cells, low blood platelet counts, low red blood cell count, elevated liver enzymes and decreases in albumin, a protein found in blood.
Yondelis carries a warning alerting health care providers of the risk of severe and fatal blood infections, muscle tissue breakdown, liver damage, leakage around the vein or catheter, tissue necrosis and heart failure. Patients with known hypersensitivity to trabectedin, a drug used to treat cancer, should not take Yondelis.
Health care providers are also encouraged to advise women of potential risks to a developing fetus when taking Yondelis. Women who are taking Yondelis should not breastfeed.
