Janssen Research & Development, LLC (Janssen) announced that the US 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.
Soft tissue sarcomas are a type of cancer originating in the soft tissues that connect, support and surround other body structures, such as muscle, fat, blood vessels, nerves, tendons and the lining of joints. In the US, nearly 12,000 people will be diagnosed and approximately 4,870 are expected to die of soft tissue sarcomas in 2015. Leiomyosarcoma is an aggressive type of soft tissue sarcoma that occurs in smooth muscles, such as those in the uterus, gastrointestinal tract or lining of blood vessels. Liposarcoma originates in fat cells and most commonly occurs in the thigh and abdominal cavity, though it can occur in fat cells in any part of the body.
Yondelis (trabectedin) is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The anti-cancer medicine works by preventing the tumor cells from multiplying and is approved in 77 countries, within North America, Europe, South America and Asia, for the treatment of advanced soft-tissue sarcomas as a single-agent, and in 70 countries for relapsed ovarian cancer in combination with Doxil/Caelyx (doxorubicin HCl liposome injection).
Under a licensing agreement with PharmaMar, a wholly owned member of the Zeltia Group, Janssen Products, LP has the rights to develop and sell Yondelis globally except in Europe, where PharmaMar SA holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals Co., Ltd. If approved in the US, Yondelis would be commercialized by Janssen Biotech, Inc.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.