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  • FDA approves Orgovyx for prostate cancer.- Myovant...
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FDA approves Orgovyx for prostate cancer.- Myovant Sciences

Read time: 1 mins
Published:19th Dec 2020
The FDA has approved Orgovyx (relugolix), from Myovant Sciences, for the treatment of adult patients with advanced prostate cancer. The safety and efficacy of Orgovyx was evaluated in a randomized, open-label trial in men with advanced prostate cancer. The patients randomly received either Orgovyx once daily or injections of leuprolide, another hormone-targeting drug, every three months for 48 weeks. The objective was to determine if Orgovyx achieved and maintained low enough levels of testosterone (castrate levels), by day 29 through end of the treatment course. In the 622 patients who received Orgovyx, the castration rate was 96.7%.The most common side effects of Orgovyx include: hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea and increased levels of certain liver enzymes. Concurrent use of Orgovyx with drugs that inhibit P-glycoprotein, which plays a role in pumping toxins out of cells, is contraindicated. Androgen deprivation therapies such as Orgovyx may affect the heart's electrical properties or cause electrolyte abnormalities, therefore healthcare providers should consider periodic monitoring of electrocardiograms and electrolytes. Based on findings in animals and the mechanism of action, Orgovyx can cause fetal harm and loss of pregnancy when administered to a pregnant female; it is advised that males with female partners of reproductive potential use effective contraception during treatment and for two weeks after the last dose of Orgovyx. Due to the drug's suppression of the pituitary gonadal system, diagnostic test results of the pituitary gonadotropic and gonadal functions conducted during and after taking Orgovyx may be affected.
Condition: Prostate Cancer
Type: drug

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