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Yondelis® Approved for Soft Tissue Sarcoma

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The United States Food and Drug Administration (FDA) approved the chemotherapy agent, Yondelis (trabectedin), for the treatment of liposarcoma and leiomyosarcoma – two types of soft-tissue sarcomas.

The approval of trabectedin is for patients whose cancer is not able to be removed by surgery and/or has spread to distant sites in the body

This treatment is approved for patients who previously received chemotherapy that contained anthracycline.

Liposarcoma and leiomyosarcoma are both types of soft-tissue sarcomas. Soft tissue refers to tissue that supports, connects or surrounds other structures or organs in the body. Soft tissue can include fat, muscle, nerve, tendons, blood vessels and lymph vessels.

Liposarcoma refers to a soft-tissue sarcoma that starts in fat cells. Leiomyosarcoma refers to a soft-tissue sarcoma that starts in smooth muscle. Smooth muscle is the type of muscle that acts involuntarily, meaning there is no voluntary control over the contraction or relaxation of the muscle. Examples of smooth muscle are the digestive system, uterus, skin or salivary glands.

Soft-tissue sarcomas can occur at several different sites in the body; wherever fat cells and smooth muscle are located.

Researchers recently conducted a multicenter, phase III clinical trial to directly compare trabectedine to dacarbazine in patients with liposarcoma or leiomyosarcoma. The trial included 518 patients with metastatic soft-tissue sarcoma (cancer spread to distant sites in the body) who had received prior therapy with an anthracycline (type of chemotherapy), in addition to at least one other standard therapeutic regimen.

Median progression-free survival (survival without progression of cancer) was 4.1 months for patients treated with trabectedin, compared with only 1.5 months for those treated with dacarbazine.
The most common severe side effects of trabectedin were low levels of blood cells and elevated levels of liver enzymes.
Reference: United States Food and Drug Administration. FDA approves new therapy for certain types of advanced soft tissue sarcoma. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm468832.htm. Accessed October 23, 2015.