The Relugolix got approval from U.S. Food and Drug Administration for treating advanced prostate cancer in adult patients.
Relugolix is administered through the oral route, which inhibits the pituitary gland from producing follicle-stimulating hormone and luteinizing hormone. Thus it decreases the testosterone amounts which are produced by the testicles.
The safety and efficiency of Relugolix were assessed in a randomized, open-label trial in advanced prostate cancer patients. Patients were randomly given either Relugolix one time a day or leuprolide injections, which is a hormone-targeting drug, every three months (for 48 weeks). The aim was to find if Relugolix can achieve and maintain sufficient low levels of testosterone. Among six hundred and twenty-two patients who administered Relugolix, 96.7% was the castration rate.
The most common side effects of this drug are hot flush, constipation, increased glucose, diarrhoea, increased triglycerides, fatigue, musculoskeletal pain, decreased haemoglobin etc. The androgen deprivation treatments such as Relugolix might influence the electrical properties of heart or generate electrolyte abnormalities. Thus, periodic monitoring of electrolytes and electrocardiograms should be considered. Relugolix can cause harm to fetus and loss of pregnancy if received by a pregnant woman. Thus it is advised that males use efficient contraceptive if their female partner is of reproductive potential during the therapy and after the last dose of Relugolix for two weeks.
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Source: |
FDA |
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Link to the source: |
https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-hormone-therapy-treating-advanced-prostate-cancer [Last accessed on: 6 January, 2021] |
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Original title of article: |
FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer |
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Translated by: |
