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GTx, Inc. (Nasdaq: GTXI) 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.
GTx is assessing the ability of enobosarm to prevent and treat muscle wasting in non-small cell lung cancer patients in two pivotal Phase III clinical trials, POWER 1 and POWER 2. In each of the placebo-controlled, double-blind clinical trials, approximately 300 patients with Stage III or IV non-small cell lung cancer have been randomized to oral daily doses of placebo or enobosarm 3 mg at the time they began first line standard platinum doublet chemotherapy. The studies are evaluating as co-primary endpoints at three months of treatment the responder rates of enobosarm versus placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry and improving physical function measured by the Stair Climb Test. Durability of the drug effect is being evaluated as a secondary endpoint at five months of treatment.
“We are very pleased that FDA has recognized enobosarm as a drug candidate with the potential to address the serious and unmet medical need of preventing and treating muscle wasting in non-small cell lung cancer patients,” said Mitchell Steiner, MD, CEO of GTx. “With approximately 650 patients fully enrolled in our two definitive Phase III clinical studies of enobosarm, we expect to receive top line data from these studies this summer. Assuming the data supports our ability to do so, we will move quickly to meet with FDA to discuss the filing of a new drug application for enobosarm.”