December 18, 2020
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FDA approves Orgovyx, first oral hormone therapy for advanced prostate cancer

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The FDA approved relugolix for the treatment of men with advanced prostate cancer.

Relugolix (Orgovyx, Myovant Sciences) is a once-daily oral gonadotropin-releasing hormone receptor antagonist that reduces production of testicular testosterone — which stimulates prostate cancer growth — and ovarian estradiol, which stimulates growth of endometriosis and uterine fibroids.

Richard Pazdur
Richard Pazdur

“[This] 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,” 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, said in a press release. “This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic.”

More than 190,000 men in the United States are diagnosed with prostate cancer each year, according to American Cancer Society.

Men with advanced disease often undergo androgen deprivation therapy, through which drugs reduce levels of hormones that contribute to growth of prostate cancer cells.

Until now, all FDA-approved treatments of this nature were designed to be injected or placed as implants under the skin.

The FDA based the approval in part on results of a randomized, open-label trial in which researchers randomly assigned men with advanced prostate cancer to relugolix once daily or injections of the hormone-targeting drug leuprolide every 3 months for 48 weeks.

Levels of testosterone — or castrate levels — from day 29 through the end of treatment served as a key study objective. Researchers reported a 96.7% castration rate among the 622 men assigned relugolix.

The most common adverse events reported among relugolix-treated men include hot flushes, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea and increased levels of certain liver enzymes.

The FDA previously granted priority review to relugolix for this indication.