GTx announced in a company media release that it has requested that the FDA consider its new drug application (NDA) for the use of toremifene 80 mg to prevent bone fractures in men with prostate cancer receiving androgen deprivation therapy (ADT).
GTx has asked for a priority review of its application stating that “there are no FDA approved treatments for its intended use.”
GTx’s main competitor with the drug zoledrenate (Zometa), Novartis, might argue against GTx receiving priority consideration from the FDA review panel. The question will pivot around whether or not Zometa is approved for the prevention of fractures in men receiving ADT. Since Zometa is approved for the treatment of patients with documented bone metastases from solid tumors one could argue that it is not approved for the prevention of bone mets nor for the prevention of bone fractures, even though many men with prostate cancer take Zometa purely for bone protction.
This issue is more than splitting technical hairs about the language. It would be entirely reasonable to hear of an insurance company denying coverage for Zometa when it is prescribed for bone protection, one of its most common uses in prostate cancer treatment.
It is a shame that we need to be concerned that in pursuit of profits one big pharmaceutical company might try and block another company, at the peril of men with prostate cancer. If Novartis (in all fairness I do want to say that as of this time they have not taken any action to block GTx’s application) slows the process for GTx receiving approval men with prostate cancer would be the ones who will suffer.
GTx’s European development partner, Ipsen Group, is also planning to submit a similar application to market toremifene 80 mg to the European Medicines Agency early next year.
Joel T Nowak MA, MSW