Yondelis gets complete response

Johnson & Johnson (NYSE:JNJ) subsidiary Centocor Ortho Biotech Products said it received a complete response letter from FDA for an NDA for Yondelis trabectedin in combination with Doxil doxorubicin to treat relapsed ovarian cancer. The company said the agency requested additional overall survival data from the ongoing Phase III OVA-301 trial and additional clinical pharmacology studies. In July, FDA's Oncologic Drugs Advisory Committee voted 14-1 that Yondelis plus Doxil did not represent a favorable benefit-risk ratio for the indication (See BioCentury, July 20, 2009). ...