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FDA Approves Trabectedin to Treat Two Types of Soft Tissue Sarcoma

December 4, 2015, by NCI Staff

Soft tissue sarcoma forms in soft tissues of the body, including muscle, tendons, fat, blood vessels, lymph vessels, nerves, and tissue around joints.

On October 23, the Food and Drug Administration (FDA) approved trabectedin (Yondelis®) for the treatment of two subtypes of soft tissue sarcomas: liposarcoma and leiomyosarcoma. The approval is for patients whose cancers are advanced or cannot be removed by surgery and who have already been treated with anthracycline-based chemotherapy.

The FDA based the approval on the results of a randomized clinical trial in which more than 500 patients with metastatic or recurrent liposarcoma or leiomyosarcoma were randomly assigned to receive trabectedin or the chemotherapy drug dacarbazine. Patients treated with trabectedin had longer progression-free survival than patients who received dacarbazine: 4.2 months versus 1.5 months. There was no difference in overall survival.

Common side effects seen in patients treated with trabectedin included nausea, fatigue, and diarrhea. The FDA also advised that treatment with trabectedin carries a risk of several serious side effects, including blood infections, muscle tissue breakdown, and liver damage.

"Anthracycline is a standard therapy for soft tissue sarcomas based on historical evidence of disease control and objective responses in 10 to 25 percent of patients," Christopher Heery, M.D., of the Laboratory of Tumor Immunology and Biology in NCI’s Center for Cancer Research.

"The approval of trabectedin for patients with advanced liposarcoma and leiomyosarcoma provides an additional treatment option for two diseases that are not amenable to surgical intervention and who have very few treatment options."

Like most sarcomas, liposarcoma and leiomyosarcoma have proven to be resistant to standard chemotherapy and other targeted therapies, Dr. Heery said. Progress against different soft tissue sarcomas subtypes may have been limited to date, he continued, because in clinical trials patients with sarcomas have traditionally been grouped together, limiting the analysis of more distinct subtypes.

"Studies that focus on particular sarcoma subtypes, such as the one on which the approval is based, may provide greater opportunity to identify incremental improvements," he said.

Through NCI’s Natural Products Branch, trabectedin was originally isolated from a marine organism called a sea squirt. The drug, which is now chemically synthesized, is also being tested as a treatment for ovarian and other cancers.

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