Zeltia has suffered a setback with the news that partner Johnson & Johnson has withdrawn a filing with US regulators for the Spanish drugmaker's cancer treatment Yondelis.
J&J's Centocor Ortho Biotech unit announced that it has voluntarily withdrawn the New Drug Application for Yondelis (trabectedin) for the treatment of recurrent ovarian cancer. The decision is based on the US Food and Drug Administration's recommendation that an additional Phase III study be conducted.
In September 2009, the FDA issued a complete response letter regarding the NDA for Yondelis when administered in combination with J&J’s Doxil (doxorubicin). The agency wanted to see overall survival data from the pivotal OVA-301 trial and additional clinical pharmacology studies.
J&J noted that the OVA-301 overall survival data will be presented in June at the annual meeting of the American Society of Clinical Oncology, adding that it is evaluating the development programme for Yondelis in recurrent ovarian cancer: the US healthcare giant recently initiated a Phase III study with trabectedin for metastatic L-sarcoma.
Last week, Zeltia was hit by the news that the National Institute for Health and Clinical Excellence rejected the Yondelis/Doxil combo for use in ovarian cancer patients because it had concerns over its efficacy compared with standard therapies; it was approved for ovarian cancer in Europe in November 2009 and has been available for the treatment of advanced soft tissue sarcoma since September 2007.