The U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for trabectedin to treat patients with advanced soft-tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline. The NDA for trabectedin was submitted to the FDA on November 24, 2014.
Trabectedin is a novel, multimodal, synthetically produced antitumor agent—originally derived from the sea squirt Ecteinascidia turbinata—that prevents tumor cells from multiplying.
The filing is based on the phase III randomized, open-label study ET743-SAR-3007. This trial is evaluating the safety and efficacy of trabectedin vs dacarbazine for the treatment of patients with advanced liposarcoma and leiomyosarcoma. Results will be presented at a later date. ■