Product News and Recalls

GTx Drug to Treat Muscle Wasting Fails to Meet Late-Stage Requirements

A drug designed to treat cancer-induced muscle wasting has failed its late-stage development trials. A story by Reuters reports that the drug, named enobosarm, did not meet its requirements to improve body mass and physical function in cancer patients. The manufacturer, GTx Inc, will therefore not be receiving FDA approval for its new drug.

Enobosarm was tested on about 650 patients with non-small cell lung cancer and did not meet any of the pre-specified requirements. The patients showed no significant improvement in muscle wasting which causes decreased physical function, fatigue and weight loss.

GTx Inc, a cancer-focused pharmaceutical company has lost two-thirds of its market value, once $800 million. This is the second major drug failure after its prostate cancer drug was rejected by the FDA in 2010. The company looks to begin working on a new drug to treat advanced prostate cancer called Capesaris. An analyst for Cowen and Co, states “We are not optimistic for Capesaris’s success, and believe GTx will require significant capital to continue its development.”

Executives at GTx appear optimistic that enobosarm could potentially increase survival by improving body mass. Although one study did show improvements to body mass, it failed to meet the requirement to improve physical function and survival. The company plans further trials and testing with the FDA to get the drug approved in the future.

You should consult a medical professional before altering your medical care.