FDA Puts GTx Drug for Cancer Patients on "Fast Track"


Small-cap cancer researcher GTx announced Tuesday that the U.S. Food and Drug Administration has granted "fast track" development status to its enobosarm (GTx-024) drug for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer.

Fast track status enables expedited development and regulatory review of test results for new drug candidates that target serious, currently untreated or insufficiently treated diseases. GTx said in a statement that the fast track designation gives it a greater chance of winning "priority review" for a New Drug Application for enobosarm. The company is currently conducting two phase III clinical trials of the drug, designated POWER 1 and POWER 2, testing its effects on patients suffering from stage III and IV non-small cell lung cancer.

The company says it expects to have top line data from these studies this summer.


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