Antigenics submits MAA for Oncophage

USA-based Antigenics has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) requesting approval of its cancer vaccine Oncophage in earlier-stage, localized renal cell carcinoma under the conditional authorization provision.

Currently, there are no EMEA-approved drug therapies for this patient population. If cleared, Oncophage will be the first therapeutic cancer vaccine to receive a marketing license from European regulators. Unlike the cervical cancer vaccines Gardasil or Cervarix, Oncophage enhances the body's immune response to cancer cells that have already developed rather than preventing them occurring.

The product received European Orphan Drug status in 2005, which offers the potential for 10 years of market exclusivity and would allow authorization to market Oncophage in all 27 European Union member states and non-members including Norway and Iceland. In addition to findings from a Phase III kidney cancer trial, the largest completed to date in the adjuvant setting, the application included data from 14 other studies conducted with Oncophage.