2007: Trabectedin (ET-743, Yondelis®) first anti-cancer drug from marine origins approved in Europe

Nominated by: Spanish Bioindustry Association – AseBio 

Organisation in nomination: Pharmamar (Spain)             

Marine environments are considered more biologically diverse than terrestrial environments. Thirty-two different animal phyla are represented in the oceans of the 33 recognized phyla. Fifteen different phyla are represented only in marine environments, while only 1 is exclusively terrestrial.  This creates a rich potential source of novel products for application into healthcare.

In 1969, as part of an NIH-funded programme, extracts from the sea squirt Ecteinascidia turbinata were determined to have anti-cancer properties, with the active molecule Ecteinascidin 743 identified.  Spanish company Pharmamar licensed the rights from the University of Illinois in 1994 and developed a production process for the molecule  starting from safracin B, an antibiotic obtained by fermentation of the bacterium Pseudomonas fluorescens.

In 2007, the resulting product Trabectedin, was the first anticancer marine-derived drug to be approved by the European Union, obtaining marketing authorization from the European Commission and in many other countries for the treatment of patients with advanced soft tissue sarcoma (STS) after failure of anthracyclines and ifosfamide, or for those patients who are unsuitable to receive these agents.

In 2009 the European Commission further granted marketing authorization for trabectedin combined with PLD for the treatment of patients with relapsed platinum-sensitive ovarian cancer, following results of a large phase III study (OVA-301) comparing pegylated liposomal doxorubicin (PLD) alone with a combination of PLD and trabectedin in patients with recurrent ovarian cancer.



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