GenVec’s TNFerade Gets FDA’s Orphan Drug Designation

The US Food and Drug Administration (FDA) has granted orphan drug designation to GenVec’s TNFerade, for the treatment of pancreatic cancer.

The company said that 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.

Paul Fischer, president and CEO of GenVec, said: “Orphan drug designation is a critical step for the development of TNFerade and will strengthen the TNFerade program at GenVec by offering potential clinical development and commercialization benefits.”

According to GenVec, 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.

TNFerade is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNFa), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors.