Swissmedic clears Yondelis in STS

16 February 2009

Swissmedic, the Swiss Agency for Therapeutic Products, has approved Spanish drugmaker PharmaMar's Yondelis (trabectedin) for the treatment  of soft tissue sarcoma.

PharmaMar, which is part of the Zeltia Group, has the distribution  license for the product in Switzerland, which guarantees the drug's  launch. The country joins the 30 members of the European Economic Area  where Yondelis is already cleared for marketing.

PharmaMar is also conducting clinical trials to expand the use of  Yondelis in sarcoma, such as a Phase III multicenter study of the agent  as first-line therapy in patients with tumor translocation, and a Phase  II study in children diagnosed with Ewing Sarcoma, Rhabdomyosarcoma, and  other types of STS. Yondelis is being studied in solid tumors with high  incidence and prevalence, such as prostate, breast and lung cancer.

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