Janssen Research & Development, LLC, part of Johnson & Johnson, has submitted a new drug application (NDA) for Yondelis (trabectedin) to the US 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.

Yondelis is a multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The anti-cancer medicine works by preventing the tumor cells from multiplying. It  is approved in 76 countries in North America, Europe, South America, and Asia for the treatment of advanced soft-tissue sarcomas as a single-agent, and in 69 countries for relapsed ovarian cancer in combination with Doxil/Caelyx (doxorubicin HCl liposome injection).

Under a licensing agreement with PharmaMar, a wholly owned member of the Zeltia Group, Janssen Products, LP has the rights to develop and sell Yondelis globally except in Europe, where PharmaMar SA holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals Co., Ltd. If approved in the US, Yondelis would be commercialized by Janssen Biotech, Inc.

Source: Johnson & Johnson