FDA Approves Yondelis (Trabectedin) for Advanced Soft Tissue Sarcoma

The US Food and Drug Administration (FDA) has approved the chemotherapy drug Yondelis (trabectedin) to treat 2 types of soft tissue sarcomas – liposarcoma and leiomyosarcoma – that have spread to other parts of the body and/or cannot be removed through surgery. The treatment is for people who have already received anthracycline chemotherapy drugs.

Liposarcoma is a cancer that starts in fat cells, while leiomyosarcoma starts in smooth muscle cells. There are few options for treating these types of soft tissue sarcomas in the advanced stages.

The FDA based its approval on a study of 518 people with advanced liposarcoma or leiomyosarcoma who were randomly assigned to treatment with Yondelis or another chemotherapy drug, dacarbazine. Those who received Yondelis had a longer time after starting treatment before their tumor started to grow (about 4.2 months) compared with an average of 1.5 months for those who received dacarbazine. Yondelis was not shown to help patients live longer.

The most common side effects of Yondelis were nausea and vomiting, fatigue, diarrhea, constipation, decreased appetite, shortness of breath, headache, swelling in the legs, a decrease in infection-fighting white blood cells, low blood platelet counts, low red blood cell counts, elevated liver enzymes, and decreases in albumin, a protein found in blood.

Yondelis carries a boxed warning, which is the FDA’s strongest warning for drugs that have serious side effects. The warning is about the risk of severe and fatal blood infections, muscle tissue breakdown, liver damage, leakage of the drug around the vein or catheter, tissue breakdown, and heart failure.

Women who are pregnant should be warned of possible risks to a developing fetus from taking Yondelis. Women who are taking the drug should not breastfeed.

Yondelis is marketed by Janssen Products.