The designation is based on GenVec having ‘provided evidence of the potential to improve survival in patients with pancreatic cancer’. 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, the company said.
Should events warrant, GenVec will be eligible to submit a US 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. GenVec is developing TNFerade for use in combination with radiation or chemotherapy for the treatment of various cancers.
Mark Thornton, senior vice president of product development at GenVec, said: “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. As further data emerge regarding TNFerade, we look forward to working closely with the FDA to potentially expedite the review process for TNFerade.”