Yondelis filed with FDA for STS - Janssen

Janssen Research & Development has submitted a New Drug Application (NDA) for Yondelis (trabectedin) to the FDA for the treatment of patients with advanced Soft Tissue Sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline. Janssen also announced plans to amend the protocol for the Phase III randomized, open-label study ET743-SAR-3007, on which the NDA submission is based. The protocol will be revised to offer patients who were randomized to the dacarbazine comparator arm the option of receiving trabectedin treatment at their physician's discretion.

This trial is evaluating the safety and efficacy of trabectedin versus dacarbazine for the treatment of advanced liposarcoma and leiomyosarcoma, the most common types of STS in adults, in more than 500 patients previously treated with an anthracycline and ifosfamide, or an anthracycline followed by one additional line of chemotherapy. Results of the study will be presented at a future date.