Point Therapeutics, Inc., a Boston-based biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted talabostat fast track designation for the treatment of Stage IIIB/IV non-small cell lung cancer (NSCLC) patients who have failed prior platinum-based chemotherapy.
"The fast track designation is a significant milestone for talabostat and an important step in moving forward with the development process. The designation recognizes the serious unmet medical need of patients with metastatic non-small cell lung cancer who have failed prior platinum-based chemotherapy and the potential of talabostat to impact this disease," said Dr. Margaret Uprichard, Senior vice president and chief scientific office of Point Therapeutics. "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."
Talabostat's novel dual mechanism of action and positive results from the phase 2 study combining talabostat with docetaxel (64 per cent second-line patients and 36 per cent third-line patients) were the key components of the application for Fast Track designation in metastatic NSCLC. In the phase 2 study, 55 patients were enrolled--42 of whom met evaluability criteria for response. Six patients demonstrated a clinical response to treatment as defined by World Health Organization criteria (a 50 per cent or greater reduction in tumour size) for an overall response rate of 14.3 per cent. Two of these patients had a complete response, defined as a complete disappearance of their tumour. In all 55 patients, median progression-free survival is 4.2 months and one year survival is 38 per cent.
Under the FDA Modernization Act of 1997, the fast track programme of the FDA is designed to facilitate the development and expedite the review of a new drug that is intended for the treatment of a serious or a life-threatening condition, and demonstrates the potential of a drug candidate to address unmet medical needs for such a condition. 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 3 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. The first 400-patient trial, evaluating the combination of talabostat with docetaxel versus placebo and docetaxel opened to enrolment in October 2005. The second 400-patient trial, evaluating the combination of talabostat with pemetrexed versus placebo and pemetrexed opened to enrolment in February 2006. The primary study endpoint is progression-free survival. Secondary endpoints include overall survival, objective response rate, duration of response and quality of life. Trial results for both studies are projected for late 2007.