Yondelis® (trabectedin) is an antitumour agent of marine origin discovered in the colonial tunicate Ecteinascidia turbinata. It is currently produced by chemical synthesis.
Yondelis® has a unique action mechanism. It binds to the minor groove of the DNA and interferes with cell division and the gene transcription processes and repair machinery of the DNA.
In September 2007, it received marketing authorisation from the European Commission for the treatment of advanced or metastatic soft tissue sarcoma. In November 2009 Yondelis® has received its second marketing authorisation from the European Commission for the treatment of relapsed platinum-sensitive ovarian cancer in combination with DOXIL®/Caelyx®
Yondelis® has been designated an orphan drug by the European Commission (EC) and the USA Food and Drug Administration (FDA) for soft tissue sarcoma and ovarian cancer.
PharmaMar markets Yondelis® in Europe and Japan and Ortho Biotech Products, L.P. does so in the United States and the rest of the world.
Phase II trials with Yondelis® are also being carried out for breast cancer and for paediatric tumours. Another Phase III trial is on going for soft tissue sarcoma in first line of treatment.