FDA approves Janssen's Yondelis for advanced soft tissue sarcomas

The US Food and Drug Administration on Friday approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) - liposarcoma (LPS) and leiomyosarcoma (LMS) - that cannot be removed by surgery (unresectable) or is advanced (metastatic).

This treatment, from Janssen - a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), is approved for patients who previously received chemotherapy that contained anthracycline. While approved for both LPS and LMS, Yondelis is the first treatment to be specifically approved for LPS in the USA, said Janssen. The drug was first cleared in Europe in 2007 and is now approved in mor0e than 70 countries.

According to the National Cancer Institute, STS is a disease in which cancer cells form in the soft tissues of the body, including the muscles, tendons, fat, blood vessels, lymph vessels, nerves and tissues around joints. Liposarcoma and leiomyosarcoma are specific types of STS that occur in fat cells (liposarcoma) or smooth muscle cells (leiomyosarcoma). STS can form almost anywhere in the body, but is most common in the head, neck, arms, legs, trunk and abdomen. In 2014, an estimated 12,000 cases of STS were diagnosed in the United States.