WASHINGTON—The FDA approved relugolix (Orgovyx) for treatment of advanced prostate cancer—this is the first approval for a oral drug for androgen deprivation therapy.
In making the announcement, Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said the availability of an oral agent may may eliminate the need for clinic visits for injections. “This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic.”
Relugolix blocks the production luteinizing hormone and follicle-stimulating hormone, thereby reducing the amount of testosterone the testicles are able to make.
The approval was based on results from a randomized, open-label trial in men with advanced prostate cancer. The patients randomly received either “relugolix once daily or injections of leuprolide, another hormone-targeting drug, every three months for 48 weeks. The objective was to determine if [relugolix] 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 [relugolix], the castration rate was 96.7%.”
The most common side effects include: hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea and increased levels of certain liver enzymes.
“Concurrent use of [relugolix] with drugs that inhibit P-glycoprotein, which plays a role in pumping toxins out of cells, is contraindicated.”
As with standard androgen deprivation therapy, there is an increased risk of heart rhythm problems or electolyte abnormalities. “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 relugolix may be affected.
Peggy Peck, Editor-in-Chief, BreakingMED™
Cat ID: 25
Topic ID: 78,25,25,192,241,73,925