GTx Announces FDA Fast Track Designation for Enobosarm

GTx

today announced that the U.S. Food and Drug Administration (FDA) has designated enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer as a Fast Track development program. Fast Track status is a process designed by FDA to facilitate the development and expedite the review of new drug candidates that are intended to treat serious diseases and have the potential to fill an unmet medical need. With a Fast Track designation, there is an increased possibility for a priority review of a new drug application (NDA) filed for the drug candidate and more opportunity for more frequent interactions with the FDA both prior to and following the filing of a NDA.