J&J withdraws Yondelis NDA

Johnson & Johnson (NYSE:JNJ) withdrew an NDA for Yondelis trabectedin to treat relapsed ovarian cancer after FDA recommended an additional Phase III trial. The pharma would not disclose details about FDA's recommendation and said it is evaluating the development program for Yondelis in the indication.

In 2009, J&J received a complete response letter from FDA for the NDA requesting additional overall survival (OS) data from the ongoing Phase III OVA-301 trial. At that time, FDA did not recommend an additional trial. J&J said the requested OS data will be presented at the American Society of Clinical Oncology meeting in Chicago in June (see BioCentury Extra, Sept. 10, 2009). ...