Janssen R&D and PharmaMar announced that the FDA has granted Priority Review to the New Drug Application (NDA) for Yondelis (trabectedin). Yondelis is being developed for the treatment of patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.
The filing is based on the Phase 3 randomized, open-label study ET743-SAR-3007 which evaluated the safety and efficacy of trabectedin vs. dacarbazine for the treatment of patients with advanced liposarcoma and leiomyosarcoma previously treated with an anthracycline and ifosfamide, or an anthracycline followed by one additional line of chemotherapy.
Yondelis is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata that works by preventing the tumor cells from multiplying.
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