FDA Grants Priority Review for Trabectedin for the Treatment of Patients With Advanced Soft-Tissue Sarcoma
Janssen Research & Development, LLC, announced today that 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 turbinate, 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, the most common types of soft-tissue sarcoma in adults, in more than 500 patients previously treated with an anthracycline and ifosfamide, or an anthracycline followed by one additional line of chemotherapy. Results of the study will be presented at a future date.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
