FDA Approves first Oral Hormone Therapy for Treating Advanced Prostate Cancer
The FDA has approved relugolix an oral androgen deprivation therapy ADT for men with advanced prostate cancer. The FDA granted approval of Orgovyx to Myovant Sciences.
"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, M.D., 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. "This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic."
The American Cancer Society estimates that in 2020, there will have been more than 190,000 cases of prostate cancer in the U.S. One of the treatment options for advanced prostate cancer is androgen deprivation therapy, which uses drugs to lower levels of the hormones that help prostate cancer cells grow. Current FDA-approved treatments of this type are injected or placed as small implants under the skin. Orgovyx is an orally administered treatment that 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.
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