FDA Grants Orphan Drug Designation for TNFerade

The US Food and Drug Administration has granted orphan drug designation to GenVec, Inc.'s TNFerade for the treatment of pancreatic cancer.

TNFerade, which has not yet been approved for use, is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNF-alpha), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNF-alpha in the tumor. TNFerade has been granted Fast Track product designation by the FDA for its proposed use in the treatment of locally advanced pancreatic cancer.

The FDA grants orphan drug designation to drugs that may provide a significant therapeutic advantage over existing treatments and target conditions affecting 200,000 or fewer US patients per year. Orphan drug designation provides potential financial and regulatory incentives including study design assistance, waiver of FDA user fees, tax credits, and up to seven years of market exclusivity upon marketing approval.