Toremifene citrate regulatory update

FDA issued a complete response letter to GTx for toremifene 80 mg to reduce fractures in men with prostate cancer receiving androgen deprivation therapy. The company said FDA requested a second Phase III trial demonstrating safety and efficacy, as well as results from a clinical trial showing that toremifene does not have a detrimental effect on either time-to-disease progression or overall survival. On a conference call, GTx said it plans to meet with FDA before deciding whether to conduct a trial. It said an identical study to the completed Phase III trial for the non-steroidal selective estrogen receptor modulator (SERM) would take five years at a cost of $30-$35 million. ...