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news.GTx, a biopharmaceutical company, has announced that the FDA has accepted for filing and review the new drug application for toremifene 80mg, an oral selective estrogen receptor modulator, which the company seeks to market for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy.
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The new drug application (NDA) is supported by results from a two-year, double-blind, placebo-controlled, randomized Phase III clinical trial of 1,382 men with advanced prostate cancer on androgen deprivation therapy.
GTx expects to hear within several weeks whether the NDA will receive priority or standard review.