Update: FDA approves Orgovyx, the first oral hormone therapy of its type for treating advanced prostate cancer
|At a glance
|Questions for your doctor
|What does this mean for me?
This study is about:
This study is about the recent approval of the oral therapy, Orgovyx (relugolix), to treat advanced cancer.
Why is this study important?
(ADT) is a treatment option for advanced cancer (cancer that has spread beyond the ). ADT uses drugs to stop the body from making or using testosterone—a hormone that fuels growth of 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.
Approval of Orgovyx was based on data from the international HERO clinical trial, which included 930 men aged 18 or older who had advanced 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 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.
- Hot flashes
- Joint Pain
- Increased levels of certain liver enzymes
The 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 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.
If you have a diagnosis of advanced cancer and your doctor recommends , please discuss all options for therapy management. If you are likely to take a daily pill for your 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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Shore N, Saad F, Cookson M, et al. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Cancer. New England Journal of Medicine; June 4, 2020; 382(23):2187-2196.
Approves First Oral Hormone Therapy for Treating Advanced Cancer. News Release. Food and Drug Administration. December 18, 2020.
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
Be part of XRAY:
- What are my options for treating 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?
The following are studies looking at in people with cancer:
- NCT04666129: Study of Relugolix in Men With Castration-Sensitive Cancer or Non-Metastatic or Castration-Resistant Cancer. This study will test how safe and tolerable the drug relugolix is when used with other drugs approved for (ADT).
- NCT05100472: A Study of Shorter Course Hormone Therapy and Radiation for High-risk Cancer. The purpose of this study is to find out whether combining a shorter than standard course of hormone therapy with standard radiation therapy is a safe and effective way to prevent high-risk cancer from coming back and/or spreading.
- NCT02949284: Androgen Receptor Antagonist ARN-509 With or Without Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients With High-Risk Cancer Undergoing Surgery This study will look at how well the hormonal therapy ARN-509 works with or without and prednisone in treating patients with high-risk cancer who are undergoing surgery.
- NCT03860987: Combined With and Using Multiparametric and 18FDCFPyL PET/CT in Newly Diagnosed Cancer. The goal of this study is to develop improved techniques to localize and detect cancer; and to develop new ways to treat cancer
A number of other clinical trials for patients with cancer can be found here.
The following organizations offer peer support services for people with or at high risk for cancer:
- FORCE peer support
- Visit our message boards.
- Once you register, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Sign up for our Peer Navigation Program.
- Users are matched with a volunteer who shares their mutation and situation.
- Join our private Facebook group.
- Find a virtual or in-person support meeting.
- Join a Zoom community group meeting.
- Visit our message boards.
- ZERO-The End of Cancer is a nonprofit organization that provides information and support resources for men with cancer.
Who covered this study?
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