GTx submits NDA for toremifene

According to a company media release late yesterday, GTx has submitted a new drug application (NDA) to the US Food and Drug Administration for the use of toremifene 80 mg to prevent bone fractures in men with prostate cancer receiving androgen deprivation therapy (ADT).

Arguing that “there are no FDA approved treatments for its intended use,” GTx has requested a priority review for toremifene 80 mg. A priority review would theoretically accelerate the time to approval for toremifene — if the data submitted support approval.

People at Novartis may contest the idea that there are no approved treatments for the prevention of fractures in men receiving ADT. The precise wording of one of the indications of zoledrenate (Zometa) in the USA states that, “Zometa is … indicated for the treatment of … patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.” Technically, GTx is correct. Zometa is not indicated for the “prevention of bone fractures.” However, in 99 percent of prostate cancer patients, that is exactly how it is being used!

GTx’s European development partner — Ipsen Group — is planning to submit an application to market toremifene 80 mg to the European Medicines Agency early next year.

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