Yondelis trabectedin regulatory update

FDA accepted and granted Priority Review to an NDA from Johnson & Johnson’s Janssen Research & Development LLC unit for Yondelis trabectedin to treat advanced soft tissue sarcoma (STS) in patients who have received prior chemotherapy, including an anthracycline. Janssen submitted the NDA on Nov. 24, 2014. The cytotoxic alkaloid that binds the minor groove of DNA is marketed in 77 countries to treat advanced STS and 70 countries for relapsed platinum-sensitive ovarian cancer. ...