Following a priority review of the oral hormone therapy Orgovyx (relugolix), developed by Myovant Sciences GmbH, the FDA has approved its use for adults with advanced prostate cancer, setting the stage for commercialization of the drug in the first of three indications for which it has been developed.
More than 190,000 cases of prostate cancer are expected to be diagnosed in the U.S. this year, according to the American Cancer Society.
Current FDA-approved treatments for advanced prostate cancer focus on androgen deprivation and are injected or placed as small implants under the skin. The approval of Orgovyx marks a first in its class and may eliminate some patients' need to visit the clinic for treatments that require administration by a health care provider, said Richard Pazdur, FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases.
"This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic," he said.
Orgovyx, the agency said, "works by blocking the pituitary gland from making hormones called luteinizing hormone and follicle-stimulating hormone, thereby reducing the amount of testosterone the testicles are able to make."
The drug was approved on the basis of a randomized, open-label study in men with advanced prostate cancer. Called Hero, the study enrolled 934 patients, assigning them, in a 2:1 ratio, to receive either Orgovyx once daily or injections of leuprolide, another hormone-targeting drug, every three months for 48 weeks. The primary endpoint was a measure of whether Orgovyx-treated patients achieved and maintained low enough levels of testosterone, or castrate levels, by day 29 through end of the treatment course. In the 622 patients who received Orgovyx, the castration rate was 96.7%.
The most common side effects of Orgovyx in trials included hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea and increased levels of certain liver enzymes.
A combination medicine based on relugolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, remains under regulatory review in the U.S. and Europe for women with uterine fibroids, with a June 1, 2021 PDUFA date. It's also being evaluated for the treatment of women with endometriosis.
Myovant was first launched by Takeda Pharmaceuticals Co. Ltd. and Roivant Sciences Ltd. in June 2016 with an exclusive global license to relugolix, formerly known as TAK-385. Today, the company's majority shareholder is Sumitovant Biopharma Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co. Ltd. In August, Myovant entered into a three-year commercial collaboration agreement with Sunovion Pharmaceuticals Inc., another subsidiary of Sumitomo Dainippon Pharma, for services to support the planned commercialization of relugolix.
Under terms of its agreement with Takeda, Myovant will pay the Tokyo-based company a fixed, high single-digit royalty on net sales of relugolix.
The drug is being manufactured by Bushu Pharmaceuticals Ltd., of Kawagoe, Japan.