ARTICLE | Clinical News

Yondelis trabectedin: Phase III started

November 15, 2010 8:00 AM UTC

PharmaMar began the open-label Phase III INOVATYON trial to compare 1.1 mg/m 2 IV Yondelis in combination with Caelyx pegylated liposomal doxorubicin vs. platinum-based therapy in 588 patients. Yondelis is approved in the EU to treat relapsed platinum-sensitive ovarian cancer and soft tissue sarcoma. Last year, FDA issued a complete response letter for the ovarian cancer indication requesting additional OS data from the Phase III OVA-301 trial and additional clinical pharmacology studies (see BioCentury, Sept. 14, 2009). ...