YONDELIS® (trabectedin) is an anticancer agent of marine origin originally isolated from the ascidian Ecteinascidia turbinata, which was found in the Caribbean Sea. Currently, YONDELIS® is chemically produced through a semisynthetic process that involves an initial step of fermentation of the bacterium Pseudomonas fluorescens. It is the first marine-derived drug to be approved in oncology.
YONDELIS® (trabectedin) has been approved in Europe for the treatment of advanced soft tissue sarcoma and recurrent platinum-sensitive ovarian cancer (in combination with DOXIL®/Caelyx®). The drug has been approved by the US Food and Drug Administration (US FDA) and by the Japanese authorities for soft tissue sarcoma in the US and Japan, respectively. The European Commission (EC) and the US Food and Drug Administration (US FDA) YONDELIS® (trabectedin) granted orphan drug designation to trabectedin for the treatment of soft tissue sarcoma and ovarian cancer, and the drug also obtained orphan drug designation in Japan by the Pharmaceuticals and Medical Devices Agency (PMDA) for soft tissue sarcoma.
Under license agreements, Janssen Products holds the rights to develop YONDELIS® (trabectedin) in the US and rest of the world except for Japan, where Taiho Pharmaceutical has the rights to develop and commercialize the drug, and Europe where PharmaMar develops and markets YONDELIS® (trabectedin).