Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for YONDELIS® (trabectedin) to treat patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline. Janssen submitted the NDA to the FDA on November 24, 2014.
Priority Review is a designation for a drug that treats a serious condition and may offer major advances in treatment when compared to existing options. A priority review designation means the FDA's goal is to take action, following the two month period for the validation and acceptance of the NDA, within six months as compared to 10 months under standard review.
The filing is based on the Phase 3 randomized, open-label study ET743-SAR-3007. This trial is evaluating the safety and efficacy of trabectedin versus dacarbazine for the treatment of patients with advanced liposarcoma and leiomyosarcoma, the most common types of STS 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.
"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, M.D., Ph.D., Global Oncology Head, Janssen.
Janssen Research & Development, LLC