J&J Files U.S. NDA For Yondelis In Sarcoma

Janssen R&D announced that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Yondelis (trabectedin) as treatment for patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, and who have undergone prior chemotherapy including an anthracycline.

Yondelis is a multimodal, artificially produced antitumor agent that was originally discovered and derived from a sea squirt known as Ecteinascidia turbinata. As an anti-cancer drug, Yondelis keeps tumor cells from growing and spreading throughout the body. The drug is approved as treatment for advanced soft-tissue sarcomas as a single-agent as well as for relapsed ovarian cancer in combination with doxorubicin HCl liposome injection in different countries.

Janssen first collaborated with PharmaMar, a wholly owned company of the Zeltia Group, in 2011 to develop and market Yondelis around the world except Europe and Japan.

Dr. Peter F. Lebowitz, Global Oncology Head at Janssen, said, “We are particularly proud of this filing… 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.”

Concurrently, Janssen also declared its plans to change the protocol of its Phase 3 study of Yondelis on which it based its NDA. The company said it will now offer patients who were randomized to receive the comparator treatment dacarbazine the chance to receive trabectedin treatment at their physician’s discretion. The Phase 3 trial is currently assessing Yondelis’ safety and efficacy compared to dacarbazine for the treatment of advanced liposarcoma and leiomyosarcoma. The more than 500 patients involved in the trial have been previously treated with an anthracycline and ifosfamide, or an anthracycline followed by an additional chemotherapy line. Janssen said it will present the results of the study in the future.

The company also announced that it will also make changes to the expanded access program (EAP) in the U.S. for trabectedin to accept eligible patients with liposarcoma and leiomyosarcoma.