The designation means that the FDA will provide input into product development plans and may accept portions of the marketing application prior to the completion of the final registration package.
Also most, but not all, drugs that are designated for the fast track program are given priority review once a new drug application is filed. The targeted date for drugs entitled to priority review is six months compared to the more usual ten months.
The fast track program is intended to expedite the review of new therapeutics that are intended to treat serious or life threatening diseases and demonstrate the potential to address unmet medical needs.
“Recurrent, refractory head and neck cancer is a devastating and aggressive disease for which there are limited treatment options,” said Dr Nick Glover, president and CEO of Viventia. “We look forward to working with the FDA to further advance our clinical strategy for Proxinium, which has shown promising early-stage efficacy results in patients with this form of cancer.”