Antigenics Files MAA for Cancer Vaccine
Antigenics, a biotechnology company, has submitted a marketing authorization application to the European Medicines Agency requesting approval for Oncophage in earlier-stage, localized renal cell carcinoma under the conditional authorization provision.
In advance of the marketing authorization application (MAA) submission, meetings with European Medicines Agency (EMEA) representatives, including the rapporteur countries, were convened to discuss the results from the international, multicenter, Phase III kidney cancer trial as well as the company’s intention to file under the conditional approval provision.
The review of the application will be coordinated by the EMEA, with the UK authorities acting as rapporteur for the application and the French authorities as co-rapporteur.
In April 2008, Oncophage was approved in Russia for the adjuvant treatment of kidney cancer patients at intermediate risk for disease recurrence. Antigenics continues to explore other major geographical territories for regulatory approval of Oncophage.
Garo Armen, chairman and CEO of Antigenics, said: “This application represents a major achievement in the development of Oncophage, and if approved, will be the first therapeutic cancer vaccine to receive a marketing license from the European agency.”