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FDA grants priority review to Yondelis for treatment of advanced soft tissue sarcoma
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The FDA has granted priority review to Yondelis for the treatment of patients with advanced soft tissue liposarcoma and leiomyosarcoma who have received prior chemotherapy including an anthracycline, according to a press release issued by the drug’s manufacturer.
Yondelis (trabectedin, Janssen Research & Development) is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata, designed to prevent tumor cells from multiplying.
The FDA based its decision on results of the phase 3 randomized open-label ET743-SAR-3007 study. This trial is evaluating the safety and efficacy of trabectedin vs. dacarbazine in more than 500 patients with advanced liposarcoma and leiomyosarcoma who were previously treated with an anthracycline and ifosfamide, or an anthracycline followed by an additional line of chemotherapy.
"We are excited the FDA has granted Priority Review for Yondelis, as it is an important step forward in making this therapy available to physicians and those living with this aggressive disease," said Peter F. Lebowitz, MD, PhD, head of global oncology at Janssen Research & Development.