Fast Track Designation for Enobosarm for Muscle Wasting in NSCLC

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GTx, Inc. announced that the FDA has designated enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer (NSCLC) as a Fast Track development program. Enobosarm is an investigational selective androgen receptor modulator (SARM).

GTx is assessing the ability of enobosarm to prevent and treat muscle wasting in NSCLC patients in two pivotal Phase 3 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 3mg 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 vs. 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.

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