FDA clears Orgovyx, the first-of-its-kind prostate cancer treatment


Orgovyx, the first oral drug in its class, may help reduce clinic visits for men with prostate cancer. Fewer visits may be important during the COVID-19 pandemic.

Relugolix (Orgovyx, Myovant Sciences) works by blocking the pituitary gland from making luteinizing hormone and follicle-stimulating hormone, thereby reducing the amount of testosterone the testicles are able to make, FDA said in a press release.

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Current FDA-approved hormone treatments for advanced prostate cancer of this type are injected or placed as small implants under the skin.

“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,” said Richard Pazdur, MD, director of 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.

“This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic,” Pazdur added.

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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 3 months for 48 weeks.

In the 622 patients who received Orgovyx, the castration rate (measuring testosterone levels) 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.

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