SGX Pharmaceuticals Incs’, Troxatyl, an investigational drug in a pivotal Phase II/III clinical trial, has been granted fast track designation by the US Food and Drug Administration for third-line treatment of acute myeloid leukemia (AML) in adults. SGX announced in May 2005 that FDA had granted Troxatyl orphan drug designation in the US for the treatment of AML.
According to a company release, this designation may allow for the FDA to sanction company actions to expedite the development and review of a potential new drug application for Troxatyl to treat third-line AML. Fast track designation also provides the potential to seek accelerated approval in which the FDA may grant market approval based on a determination that the drug effect on a surrogate endpoint is reasonably likely to predict clinical benefit.
AML is a blood cancer that increases in incidence with age. According to the American Cancer Society, AML represents approximately 90 per cent of all acute leukemias in adults. In the United States, approximately 16,000 adult patients have AML with approximately 12,000 new patients diagnosed each year. Although induction chemotherapy, typically with Ara-C and an anthracycline, another class of chemotherapy drugs such as daunorubicin or idarubicin, results in complete remission in 50 percent to 60 per cent of patients, relapse is common and long-term survival rates are less than 20 per cent.
Fast track programmes are designed to facilitate the development and expedite the review of new drugs or biologics that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track emphasises the critical nature of close, early communication between the FDA and sponsors.
SGX Pharmaceuticals, Inc. (SGX) is a biotechnology company focused on the discovery, development and commercialization of innovative cancer therapeutics.