The CHMP has recommended Spanish pharmaceutical firm Zeltia’s drug Yondelis (trabectedin) for use in the treatment of ovarian cancer.
Zeltia has been developing Yondelis for use in combination with Johnson & Johnson’s Doxil for the treatment of ovarian cancer, but has so far failed to win a green light for the medicine in the United States.
Chairman of the struggling company Jose Maria Fernandez Sousa-Faro has predicted that sales from Yondelis could be €300 million a year in Europe and that the company could break even or make a small profit by the end of 2010.
“It’s highly probable that other countries will now approve Yondelis and that within a few months the only country which hasn’t approved it will be the United States,” said Luis Mora, Managing Director for Zeltia’s PharmaMar biotech unit.
The EU decision contrasts with the verdict of the FDA, whose experts were concerned that risks of heart and liver toxicity outweighed the limited ability of Yondelis to keep disease in check.
Yondelis is already available in Europe as a treatment for soft tissue sarcoma, a relatively rare disease affecting soft tissues such as muscle, fat and tissue around joints.