MEMPHIS, Tenn. GTx has submitted an approval application to the Food and Drug Administration for a drug to prevent bone fractures in prostate cancer patients using androgen deprivation therapy, the Memphis, Tenn.-based drug maker announced Tuesday.
The drug, toremifene, is an oral selective estrogen receptor modulator. The company wants to make the drug available in the 80 mg strength.
"[Androgen deprivation therapy] has helped improve survival for men with advanced prostate cancer," GTx chief executive officer Mitchell Steiner said in a statement. "Unfortunatley, ADT may cause unintended serious estrogen deficiency side effects, such as high risk of fractures, which can shorten survival."
Steiner said that toremifene would be the first cancer care agent for preventing fractures in men receiving ADT if approved.
Ipsen has licensed European rights for toremifene from GTx and will submit an approval application in 2009.
A phase 3 trial of 1,382 prostate cancer patients receiving ADT indicated that toremifene reduced morphometric vertebral fractures compared to placebo. GTx has requested priority review from the FDA for toremifene due to the lack of a drug for decreasing bone fractures in patients receiving ADT.