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JnJ/Janssen seek US Yondelis OK in soft tissue sarcoma

 
• By Donna Young

Johnson & Johnson subsidiary Janssen Research & Development is seeking the FDA's approval to market Yondelis (trabectedin), a multimodal synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata, as a treatment for patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy, including an anthracycline.

Johnson & Johnson subsidiary Janssen Research & Development is seeking the FDA's approval to market Yondelis (trabectedin), a multimodal synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata, as a treatment for patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy, including an anthracycline.

Janssen also revealed it plans to amend the protocol for its randomized, open-label Phase III study ET743-SAR-3007 – the trial...

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