The FDA approves the primary oral drug for the remedy of grownup sufferers with superior prostate most cancers
Today the US Food and Drug Administration approved Orgovyx (Relugolix) for the treatment of adult patients with advanced prostate cancer.
Today's approval is the first oral drug in its class and it may remove some patients from having to visit the clinic to receive treatments that need to be administered by a healthcare provider. This potential to reduce clinic visits can be especially helpful in helping cancer patients stay home and avoid exposure during the coronavirus pandemic. "
Richard Pazdur, M.D., director of the FDA's Center of Oncology Excellence and acting director of the Office of Oncological Diseases at the FDA Center for Drug Evaluation and Research
The American Cancer Society estimates that there will be more than 190,000 cases of prostate cancer in the US by 2020. One of the treatment options for advanced prostate cancer is androgen deprivation therapy, which uses drugs to lower the levels of hormones that help prostate cancer cells grow. Current FDA-approved treatments of this type are injected or placed under the skin as small implants. Orgovyx is an orally administered treatment that prevents the pituitary gland from making hormones called luteinizing hormone and follicle-stimulating hormone, which reduces the amount of testosterone the testes can make.
The safety and effectiveness of Orgovyx were evaluated in a randomized, open study in men with advanced prostate cancer. Patients were randomly given Orgovyx injections of leuprolide, another hormone-targeting drug, either once a day or every three months for 48 weeks. The aim was to determine whether Orgovyx had achieved and maintained sufficiently low testosterone levels (castrate levels) by day 29 and by the end of the course of treatment. The castration rate was 96.7% in the 622 patients who received Orgovyx.
The most common side effects with Orgovyx are: hot flashes, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea, and increased levels of certain liver enzymes. Simultaneous use of Orgovyx with drugs that inhibit P-glycoprotein, which plays a role in pumping toxins from cells, is contraindicated. Androgen deprivation therapies like Orgovyx can affect the heart's electrical properties or cause electrolyte imbalances. Therefore, healthcare providers should consider regular monitoring of electrocardiograms and electrolytes.
Based on findings in animals and the mechanism of action, Orgovyx may cause fetal harm and loss of pregnancy when administered to a pregnant woman. It is recommended that men with female partners with reproductive potential use effective contraception during treatment and for two weeks after the last dose of Orgovyx. Because of the drug's suppression of the pituitary-gonadal system, diagnostic test results of the gonadotropic and gonadal pituitary functions performed during and after taking Orgovyx may be affected.
U.S. Food and Drug Administration