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  5. Drug Trial Snapshot: ORGOVYX
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Drug Trial Snapshot: ORGOVYX

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the ORGOVYX Package Insert for complete information.

ORGOVYX (relugolix)
(or-GO-vix)
Myovant Sciences, Inc.
Approval date: December 18, 2020


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

ORGOVYX is a drug for the treatment of adults with advanced prostate cancer.

How is this drug used?

ORGOVYX is a tablet. Three tablets (total of 360 mg) are taken on the first day of treatment followed by one tablet once daily.

What are the benefits of this drug?

Because prostate cancer cells use testosterone for growth, the trial tested the ability of ORGOVYX to keep testosterone level as low as after castration.

In this trial, 97% of all patients treated with ORGOVYX reached and maintained low testosterone levels equivalent to castration level.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: All the patients were men since ORGOVYX is for the treatment of prostate cancer.
  • Race: ORGOVYX worked similarly in all tested groups.
  • Age: ORGOVYX worked similarly in patients below or above 75 years of age.

What are the possible side effects?

ORGOVYX may cause serious side effects including heart rhythm problems because of changes in electrical activity (QT prolongation). ORGOVIX may cause harm to an unborn baby.

The most common side effects of ORGOVYX include hot flushes, increased blood sugar levels, increased blood fat (triglyceride) levels, muscle and joint pain, low red blood cell count (anemia), increased liver enzymes, tiredness, constipation and diarrhea.

Were there any differences in side effects among sex, race and age?

  • Sex: All the patients were men since ORGOVYX is for the treatment of prostate cancer.
  • Race: The occurrence of side effects was similar in all tested groups.
  • Age: The occurrence of side effects was similar in patients below or above 75 years of age.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved ORGOVYX based on evidence from a clinical trial ((NCT03085095) of 930 patients 48 to 97 years old with advanced prostate cancer. The trial was conducted at 155 sites in the United States, Canada, and countries in South America, Europe and the Asia Pacific region.

Figures below summarize how many were in the clinical trial by sex, race, age and ethnicity.

Figure 1. Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trials. In total, 930 men (100%) participated in the clinical trial.

FDA Review

Figure 2. Demographics by Race

Pie chart summarizing how many patients of different races were in the clinical trial.  In total, 636 patients were White (69%), 198 patients were Asian (21%), 46 patients were African American (5%), and 50 patients were Other (5%).

*Includes Other, Multiple and Not Reported
FDA Review

Figure 3. Demographics by Age

Pie chart summarizing how many individuals of certain age groups were in the clinical trial.  In total, 173 patients were less than 65 years old (18%), 491 patients were between 65-75 years old (53%), and 266 patients were 75 year and older (29%).

FDA Review

Figure 4. Demographics by Ethnicity

Pie chart summarizing how many individuals of certain ethnicity groups were in the clinical trial.  In total, 83 patients were Hispanic or Latino (9%), 827 patients were not Hispanic or Latino (89%), and for 20 patients ethnicity was unknown (2%).

FDA Review

How were the trials designed?

There was one trial that assessed efficacy and side effects of ORGOVYX.

All patients in the trial had advanced prostate cancer. Patients were randomly assigned to receive either one ORGOVYX tablet daily (on the first day they received three tables) or an active control (leuprolide acetate) which was given as an injection under the skin every three months. The patients and healthcare providers were aware of which treatment was being given. The treatment lasted for 48 weeks.

The efficacy of ORGOVYX was assessed by the percentage of patients who achieved and maintained low testosterone level equal to castration.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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