Spanish drugmaker PharmaMar said it should be in a position to file for approval of Yondelis, its investigational treatment for soft tissue sarcomas, within the two to three months in Europe.
The news, announced today by the company alongside development partner Johnson & Johnson, brings Yondelis (trabectedin) back on the development track after being turned down by the EU’s Committee for Proprietary Medicinal products in July 2003 as a second-line treatment for advanced soft tissue sarcoma patients.
PharmaMar appealed the ruling, but was turned down once again the following November.
“After a meeting held yesterday evening with the European Medicines Evaluation Agency (EMEA), PharmaMar confirms that it will submit the dossier for marketing approval of Yondelis ... based on STS 201, a Phase II randomised trial,” said the Spanish firm in a statement.
Meanwhile, J&J 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.