The Boston-based biopharmaceutical company claims Talabostat’s dual mechanism of action and positive results from the phase II study were the key components of the application for fast track designation in metastatic NSCLC.
“This designation will allow for rolling submission of our potential New Drug Application (NDA) for talabostat–which means that sections of the NDA can be submitted and reviewed by the FDA on an ongoing basis prior to their receipt of the complete NDA.” said Dr Margaret Uprichard, senior vice president of Point Therapeutics.
Under the FDA Guidance, drugs that are granted fast track status typically represent a significant improvement in the safety or effectiveness over existing therapies.
Point’s phase III NSCLC program was initiated in October 2005 and consists of two randomized, double blind placebo controlled trials in up to 800 patients at approximately 100 sites in North America.