MYOV - Myovant Sciences scores FDA approval for Orgovyx in prostate cancer

The FDA has announced it has granted the approval to Myovant Sciences (MYOV) for Orgovyx (relugolix) in the treatment of adult patients with advanced prostate cancer.Richard Pazdur, M.D., the Director of the FDA's Oncology Center of Excellence, said, “Today's approval marks the first oral drug in this class and it may eliminate some patients' need to visit the clinic for treatments that require administration by a health care provider."Orgovyx, an oral therapy, reduce the secretion of the hormone, testosterone, by blocking the pituitary gland from making hormones called luteinizing hormone and follicle-stimulating hormone.The currently approved therapies of his type for prostate cancer are injected or placed as small implants under the skin.The approval was based on the results of a randomized, open-label trial in men with advanced prostate cancer where 622 patients who received Orgovyx achieved and maintained 96.7% of castration rate (low enough levels of testosterone) by day 29.In June, the company

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Myovant Sciences scores FDA approval for Orgovyx in prostate cancer