GTx slapped with "surprise" complete response letter for toremifene
This article was originally published in Scrip
Executive Summary
The US FDA has unexpectedly hit GTx with a complete response letter for its oral selective oestrogen receptor modulator, toremifene 80mg, for a new indication for the prevention of bone fractures in men with prostate cancer who are receiving androgen deprivation therapy (ADT) to treat their cancer.