On March 3, 2016 Janssen Products, LP reported that it has informed PharmaMar(MSE:PHM) that regulatory authorities in 6 countries have granted 10 new authorisations to sell Yondelis: five for treating relapsed platinum-sensitive ovarian cancer (ROC), in combination with Caelyx (pegylated liposomal doxorubicin), and 6 as monotherapy for treating soft tissue sarcoma (STS) (Press release, PharmaMar, MAR 3, 2016, View Source [SID:1234509347]). Schedule your 30 min Free 1stOncology Demo! The six countries that have authorised Yondelis for ROC and/or STS are SaudiArabia, Moldavia, Bangladesh, Brunei, Costa Rica and Kuwait.
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As a result, Yondelis is now approved in nearly 80 countries, 31 of which are in the European Economic Area (EEA). The European Commission approved Yondelis for soft tissue sarcoma in 2007, and at the end of 2009 they approved the sale of this
drug in combination with pegylated liposomal doxorubicin for relapsed platinumsensitive ovarian cancer.
In 2015, the U.S. Food and Drug Administration (FDA) gave Janssen Products, LP, the marketing approval for YONDELIS for the treatment of patients with unresectable or metastatic liposarcoma (LPS) or leiomyosarcoma (LMS); and the drug was also approved by the Japanese Minister of Health, Labour and Welfare to Taiho Pharmaceutical Co., Ltd. for the treatment of patients with soft tissue sarcoma.
Yondelis has orphan drug status for soft tissue sarcoma and ovarian cancer in the European Union, the United States, and Switzerland, and for soft tissue sarcoma in Japan and South Korea.
According to the licensing agreement between PharmaMar and Janssen Products, LP, PharmaMar has the rights to sell Yondelis in Europe (including Eastern Europe), while Janssen Products, LP has the rights to sell the drug everywhere else except Japan, where PharmaMar has granted a license to Taiho Pharmaceutical Co., Ltd. for the development and sale of Yondelis.
About YONDELIS (trabectedin)
YONDELIS (trabectedin) is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair. It is approved in nearly 80 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcomas as a single-agent and for relapsed ovarian cancer in combination with DOXIL/CAELYX (doxorubicin HCl
liposome injection). Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights to develop and sell YONDELIS globally except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals.