FDA News

TNFerade Receives FDA Fast Track Designation for Treatment of Pancreatic Cancer

(Nov 12, 2008)-- GenVec announced  that TNFerade has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for its proposed use in the treatment of locally advanced pancreatic cancer. The designation is based on GenVec having "provided evidence of the potential to improve survival in patients with pancreatic cancer."

Drugs designated for Fast Track are intended for the treatment of a life-threatening condition and have demonstrated the potential to address unmet medical needs. Fast track designation does not apply to a product alone but to a combination of a product and specific indication. This designation provides for expedited regulatory review. Should events warrant, GenVec will be eligible to submit a U.S. biologics license application (BLA) for TNFerade on a rolling basis. Under certain conditions, this permits the FDA to review sections of the BLA prior to receiving the complete submission.

"This Fast Track designation is an important step in the increasing focus on the clinical potential of TNFerade as a treatment for locally advanced pancreatic cancer," stated Mark Thornton, M.D., Ph.D., Senior Vice President of Product Development at GenVec. "As further data emerge regarding TNFerade, we look forward to working closely with the FDA to potentially expedite the review process for TNFerade

For more information, please visit www.genvec.com

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