Innovative Prostate Cancer Treatment Approved by the U.S. FDA
The U.S. Food and Drug Administration (FDA) announced the approval of Orgovyx (relugolix) to treat adult patients with advanced prostate cancer.
According to Basel based Myovant Sciences, Orgovyx demonstrated a 96.7 percent response rate in testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in the Phase 3 HERO clinical study.
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 can make.
“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, in a related press statement.
“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.
“Prostate cancer is a very personal journey, but the universal truth is that those of us living with this disease want better treatments and options. That is why the approval of ORGOVYX is such an exciting milestone that brings a long-awaited oral treatment option to men with advanced prostate cancer,” added Thomas Farrington, president and founder of the Prostate Health Education Network.
“It is so important for men to speak with their doctor and explore what treatment is right for them as they focus on their overall health.”
Current FDA-approved treatments of this type are injected or placed as small implants under the skin.
The safety and efficacy of Orgovyx were 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 three months for 48 weeks.
The objective was to determine if Orgovyx achieved and maintained low enough testosterone levels (castrate levels) by day 29 through the end of the treatment course. In the 622 patients who received Orgovyx, the castration rate was 96.7 percent.
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.
Androgen deprivation therapies such as Orgovyx may affect the heart’s electrical properties or cause electrolyte abnormalities; therefore, healthcare providers should consider periodic monitoring of electrocardiograms and electrolytes.
Based on findings in animals and the mechanism of action, Orgovyx can cause fetal harm and loss of pregnancy when administered to a pregnant female; it is advised that males with female partners of reproductive potential use effective contraception during treatment and for two weeks after the last dose of Orgovyx.
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 Orgovyx may be affected.
The FDA approved Orgovyx to Myovant Sciences.
“With the approval of ORGOVYX, men with advanced prostate cancer now have a new oral treatment option that has demonstrated robust efficacy and safety, all with one pill taken once-a-day,” commented Lynn Seely, M.D., CEO of Myovant Sciences, Inc.
“We have successfully built our commercial capabilities to bring this newly approved treatment to the urologists and oncologists who care for men with advanced prostate cancer, intending to establish ORGOVYX as the new standard of care. We are incredibly grateful to the men and investigators who participated in the HERO study and to the FDA for expediting the review and approval of ORGOVYX through its Priority Review pathway.”
The FDA is an agency within the U.S. Department of Health and Human Services that protects public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
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