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

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Contents

At a glance Clinical trials 
Study findings Guidelines
Side effects Questions for your doctor
What does this mean for me? Resources

 

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.


This article is relevant for:

Men with advanced prostate cancer

This article is also relevant for:

People with metastatic or advanced cancer

People with prostate cancer

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Expert Guidelines

Hormone therapies, such as androgen deprivation therapy (ADT) may be used to reduce levels of male hormones (androgens) in the body or to stop them from fueling prostate cancer cells.

According to the American Cancer Society, hormone therapy may be used:

  • if the cancer has spread too far to be cured by surgery or radiation, or if you cannot have these treatments for some other reason.
  • if the cancer remains or returns after treatment with surgery or radiation therapy.
  • along with radiation therapy as the initial treatment if you are at higher risk of the cancer coming back after treatment (based on a high Gleason score, high PSA level, and/or growth of the cancer outside the prostate).
  • before radiation to try to shrink the cancer to make treatment more effective.

The National Comprehensive Cancer Network (NCCN) consists of experts in cancer. The NCCN has guidelines related to monitoring and addressing treatment side effects with ADT. They include:

  • Low Sex Drive - ADT may reduce your desire for sex and increase your chances for erectile dysfunction. To reduce these side effects, your doctor may recommend an intermittent treatment regimen that allows altering periods of time when you are “on” and “off” ADT treatment.
  • Weakening of Bone (Osteoporosis) - To help prevent weakening of bones, the NCCN recommends taking daily supplements of calcium and vitamin D3. Prior to ADT, patients should receive a dual-energy x-ray absorptiometry (DEXA) scan, a procedure used to evaluate bone density. Another DEXA scan is recommend after one treatment with ADT.
  • Diabetes and Cardiovascular Disease - ADT increases risk for diabetes and cardiovascular diseases. Thus, screening and treatment to reduce your risk for these diseases are recommended. The NCCN noted that in African American men, ADT has been known to increase the risk of death resulting from heart issues. If you are African American, it is critical that you ask your doctor about ADT treatment risk for treating your prostate cancer.

Updated: 11/30/2021

Questions to Ask Your Doctor

  • What are my options for treating prostate cancer?
  • Is treatment with Orgovyx an option for me?
  • How long will I have to take Orgovyx?
  • What are the side effects of taking Orgovyx?
  • What are the risks and benefits of standard ADT treatment compared to Orgovyx treatment?

Open Clinical Trials

The following are studies looking at androgen deprivation therapy in people with prostate cancer: 

A number of other clinical trials for patients with early-stage breast cancer can be found here.  

Updated: 11/30/2021

Peer Support

The following organizations offer peer support services for people with prostate cance

Updated: 11/26/2021

Who covered this study?

OncLive

FDA approves Relugolix for advanced prostate cancer This article rates 4.5 out of 5 stars

Prostate Cancer Foundation

FDA approves first oral hormone therapy for advanced prostate cancer This article rates 4.0 out of 5 stars

How we rated the media

 

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