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news.Oncophage, an investigational personalized cancer vaccine developed by Antigenics, has been granted orphan drug status for the treatment of renal cell carcinoma by the European Medicines Agency.
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This designation provides Antigenics with, among other benefits, ten years of potential market exclusivity if the product is approved for marketing in the European Union (EU). The FDA previously granted orphan drug designation for Oncophage in renal cell carcinoma (RCC) in May 2002.
Derived from each individual’s tumor, Oncophage contains the ‘antigenic fingerprint’ of the patient’s particular cancer, and is designed to reprogram the body’s immune system to target only cancer cells bearing this fingerprint. Oncophage is intended to leave healthy tissue unaffected to virtually eliminate the serious side effects associated with traditional cancer treatments.
Oncophage is currently in phase III trials for RCC and metastatic melanoma, and has been granted FDA fast track and orphan drug designations in both indications.