PharmaMar, a biopharmaceutical company subsidiary of the Zeltia Group announces that Yondelis (trabectedin) has received a positive opinion from the European Medicines Agency (EMEA) for the treatment of metastatic or advanced soft tissue sarcoma.
José Maria Fernández Sousa, president of Zeltia said, "This is excellent news, firstly for the patients and their families, since a new therapeutic option is now available. Also for the PharmaMar and Zeltia employees who have devoted long years of effort and dedication in pursuit of this challenge. It is also excellent news for Spanish science as well as for the investigators from all over the world who have participated in the clinical trials and believed in the therapeutic potential of compounds of marine origin".
Yondelis is a compound of marine origin currently obtained semi-synthetically and the first anti-tumoural drug developed and produced by a Spanish biopharmaceutical company. Yondelis will also be the first new therapy to be commercialised in this indication in the last three decades. The approval of Yondelis confirms the potential of the seas as a source of new medicines and validates PharmaMar as a world leader in the field.
The positive opinion by the EMEA is based mainly on the positive results of a randomised, comparative trial of two Yondelis regimes in 270 patients with sarcomas progressing in spite of all available standard agents. The study demonstrated a statistically significant 27 per cent reduction in the risk of disease progression (primary endpoint) for patients allocated to the 24-h study arm, as well as longer progression-free survival (secondary endpoint). A 61 per cent of these patients remained alive at 12 months. This is the largest clinical trial conducted to date worldwide in this setting.
The European Commission will now consider granting marketing authorization of Yondelis in the European Union in line with the positive opinion of the EMEA. Many European patients may have access to Yondelis by the end of this year.
PharmaMar continues with the development of its oncology pipeline. This first approval converts PharmaMar into a key player within the European Pharmaceutical Industry.