Janssen Research & Development, LLC (Janssen) has submitted a New Drug Application (NDA) for Yondelis (trabectedin) to the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.

“We are particularly proud of this filing, as it represents our commitment to Yondelis and the people it may help,” said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. “The advanced soft tissue sarcoma treatment landscape has been relatively stagnant for decades and it’s our hope that Yondelis will be a new treatment option for people living with this aggressive disease.”

Janssen also announced plans to amend the protocol for the Phase 3 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.

For more details, go to: http://www.jnj.com/news/all/Janssen-Submits-New-Drug-Application-for-YONDELIS-trabectedin-to-US-FDA-for-the-Treatment-of-Patients-with-Advanced-Soft-Tissue-Sarcoma