Update: FDA approves Orgovyx, the first oral hormone therapy of its type for treating advanced prostate cancer

Contents

UPDATE AT A GLANCE

This study is about:

This study is about the recent FDA approval of the oral therapy, Orgovyx (relugolix), to treat advanced prostate cancer.
 

Why is this study important?

Androgen deprivation therapy (ADT) is a treatment option for advanced prostate cancer (cancer that has spread beyond the prostate). ADT uses drugs to stop the body from making or using testosterone—a hormone that fuels growth of prostate cancer cells.

Orgovyx is an ADT known as a luteinizing hormone releasing hormone (LHRH) antagonist. Medications of this type work by preventing the body from releasing two hormones that stimulate the testicles to make testosterone: luteinizing hormone (LH) and follicle-stimulating hormone (FSH). Halting the production of LH and FSH reduces testosterone levels.

For decades, this type of hormone therapy has been administered to patients by injection or implants placed under the skin. The recent FDA-approved drug Orgovyx is a pill taken by mouth. This new option helps some patients eliminate clinical visits that are required to inject or implant prior to ADT treatment.
 

Study findings

Approval of Orgovyx was based on data from the international HERO clinical trial, which included 930 men aged 18 or older who had advanced prostate cancer. The men were enrolled in the study from one of 155 medical centers in four continents, including the North America.

During the study, the men were divided into the following treatment groups:

• Orgovyx group: Received Orgovyx as a pill once daily for 48 weeks.
• Leuprolide group: Received leuprolide acetate (a standard androgen deprivation therapy known as a luteinizing hormone releasing hormone agonist) by injection once every three months for 48 weeks.

The goal of the treatment was to achieve and sustain a “castrate level” of testosterone (the level achieved by surgical removal of the testes) between day 29 and week 48. 

Study findings showed that:

• The Orgovyx group was more likely to achieve castrate-level testosterone than those in the Leuprolide group.
  • 97 percent of men in the Orgovyx group achieved and sustained castrate levels from day 29 to week 48.
  • 89 percent of men in Leuprolide group sustained castrate levels from day 29 to week 48.
• Risk for major cardiovascular events, a known side effect of ADT treatment, was 54 percent lower in the Orgovyx group compared with the Leuprolide group.
   

Side effects
The most common side effects associated with Orgovyx treatment included:

• Hot flashes
• Joint Pain
• Fatigue
• Constipation
• Diarrhea
• Increased levels of certain liver enzymes

The FDA warns that ADTs, such as Orgovyx, may affect the heart’s electrical properties or cause an imbalance of electrolyte minerals in your body. Regular monitoring of heart functioning during ADT treatment may be recommended by your doctor. In addition, Orgovyx may cause fetal harm or miscarriage.  The FDA advises that males with female partners who may become pregnant use effective contraception during treatment and for two weeks after the last dose of Orgovyx.
 

What does this mean for me?

If you have a diagnosis of advanced prostate cancer and your doctor recommends androgen deprivation therapy, please discuss all options for therapy management. If you are likely to take a daily pill for your prostate cancer, Orgovyx may be an option for you. If you feel as though you are not likely to remember to take a pill every day, standard treatments such as injection by healthcare providers or therapy implants may be a better fit for you.

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Posted 2/18/21

References

Shore N, Saad F, Cookson M, et al. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer. New England Journal of Medicine; June 4, 2020; 382(23):2187-2196.

FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer. FDA News Release. Food and Drug Administration. December 18, 2020.

Disclosure

FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board before publication to assure scientific integrity.