J&J’s Yondelis Gets FDA’s Priority ReviewBy
Janssen Research & Development LLC, part of Johnson & Johnson, reports 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.
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.
Source: Johnson & Johnson