Yondelis trabectedin regulatory update

FDA approved an NDA from Johnson & Johnson’s Janssen Research & Development LLC unit for Yondelis trabectedin to treat unresectable or metastatic liposarcoma or leiomyosarcoma in patients who received a prior anthracycline-containing regimen. The cytotoxic alkaloid that binds the minor groove of DNA is approved in about 80 countries for advanced soft tissue sarcoma (STS) and/or relapsed ovarian cancer in combination with Caelyx pegylated liposomal doxorubicin. Liposarcoma and leiomyosarcoma are subtypes of STS. ...