FDA grants ‘fast track’ status to GTx lung cancer drug

Posted by Samantha Powell on January 8th, 2013 | No comments

FDA grants ‘fast track’ status to GTx lung cancer drug


Michael Sheffield, Staff writer- Memphis Business Journal


The U.S. Food and Drug Administration has granted Fast Track development status to Enobosarm, a drug developed by GTx Inc.

Fast Track status is an FDA process that accelerates the development and expedites review of new drugs that are intended to treat serious diseases and have the potential to fill unmet medical needs. It also results in priority review of the drugs and more frequent interaction with the FDA during the development process.

Enobosarm is being developed to treat muscle wasting in patients with non-small cell lung cancer. The drug is currently undergoing Phase III clinical trials with 650 lung cancer patients in the U.S., Eastern Europe and South America.

In a statement, Mitchell Steiner, GTx’s CEO, said the trials are expected to yield data by 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,” Steiner said.

Shares of Memphis-based GTx’s (NASDAQ: GTXI) stock increased 1.05 percent in morning trading to $4.80 per share.


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