Antigenics Inc announced that the US Food and Drug Administration (FDA) has granted the necessary permission to allow for the export of Oncophage (vitespen) to Russia.
The Russian Ministry of Public Health approved the therapeutic cancer vaccine in April 2008 for the adjuvant treatment of kidney cancer patients at intermediate risk for disease recurrence. The FDA export license clears the way to provide patients in Russia with Oncophage, which will continue to be manufactured at the company's state-of-the-art facility in Lexington, Massachusetts.
Antigenics remains on target to submit a marketing authorization application to the European Medicines Agency (EMEA) before the end of the year as well as continuing to explore other major geographical territories for regulatory approval of Oncophage.
Renal cell carcinoma is the most common type of kidney cancer. Renal cell carcinoma accounts for about 90 per cent of all kidney tumours.
In April 2008, Oncophage was approved in Russia for the adjuvant treatment of kidney cancer patients at intermediate risk for disease recurrence.
Antigenics is a biotechnology company working to develop treatments for cancers and infectious diseases.