Yondelis finally back to FDA

The Janssen Research & Development unit of Johnson & Johnson (NYSE:JNJ) submitted an NDA for Yondelis trabectedin to treat patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.

The submission comes more than three years after the pharma withdrew an NDA for Yondelis to treat relapsed ovarian cancer after FDA recommended an additional Phase III trial (see BioCentury Extra, Oct. 13). The drug already is approved in Europe as monotherapy to treat advanced or metastatic STS and in combination with Caelyx pegylated liposomal doxorubicin for relapsed platinum-sensitive ovarian cancer. ...