Spanish company Zeltia has had another go at seeking approval in Europe for its cancer drug Yondelis, which was turned down by a European Medicines Agency advisory panel in July 2003.
Yondelis (trabectedin) was rejected by the EU's Committee for Proprietary Medicinal products in July 2003 as a second-line treatment for advanced soft tissue sarcoma, a cancer that affects around 11,000 people in Europe every year. Zeltia’s drugmaking subsidiary PharmaMar appealed the ruling, but was turned down once again the following November.
The latest application is based on the results of a randomised, Phase II pivotal study of Yondelis, known as STS-201.
Last month, Zeltia’s US partner for the drug, Johnson & Johnson, said it plans to file a New Drug Application with the US Food and Drug Administration (FDA) for Yondelis in the same indication, also based on STS-201 Phase II data, once a Phase III confirmatory trial is underway.
In addition to soft tissue sarcoma, Yondelis is being studied in a Phase III trial in ovarian cancer and in Phase II in prostate and breast cancers, and if approved in all indications could have peak sales potential of more than 1 billion euros a year.