XTANDI is a prescription medicine used to treat men with prostate cancer that:
- no longer responds to a hormone therapy or surgical treatment to lower testosterone
- has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone
OR
It is not known if XTANDI is safe and effective in females or children.
How XTANDI was studied
Metastatic castration-sensitive prostate cancer (mCSPC)
XTANDI slowed advanced prostate cancer progression.
Men taking XTANDI had a 61% lower chance of their cancer progressing compared with men not taking XTANDI during the study.
The median* length of time until the cancer got worse was not reached for XTANDI + ADT** vs. 19 months for ADT alone.
Progression was defined as the cancer getting worse, as measured by scans, or if the patient died for any reason.
*The median is not the average but the middle of a set of numbers.
XTANDI was studied in men with advanced prostate cancer that:
- Was still responsive to hormone therapy or surgical treatment to lower testosterone
- Had spread to other parts of the body
The study included 1,150 men. It compared men taking XTANDI with men not taking XTANDI.
All men either had surgery to lower testosterone or continued to take hormone therapy during the study.
In this same study, XTANDI helped men live longer.
Men taking XTANDI had a 34% reduction in the risk of death compared with men not taking XTANDI during the study.
The median length of time patients lived after starting treatment was not reached.
In addition, XTANDI delayed the median time before men began chemotherapy.
In this same study, men taking XTANDI had a 72% lower chance of starting a new chemotherapy or other cancer drugs than men not taking XTANDI.
The median time was 30 months for men taking XTANDI + ADT vs. not reached for ADT alone.
Results may vary. Talk with your doctor about what this may mean for you.
Select Safety Information
XTANDI may cause serious side effects including heart disease. Blockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with XTANDI. Your doctor will monitor you for signs and symptoms of heart problems during your treatment. Call your doctor or go to the emergency room right away if you get chest pain or discomfort at rest or with activity or shortness of breath during your treatment with XTANDI.
Metastatic castration-resistant prostate cancer (mCRPC)
XTANDI slowed advanced prostate cancer progression.
Men taking XTANDI had an 83% lower chance of their cancer progressing compared with men not taking XTANDI during the study.
The median length of time until the cancer got worse was not reached for XTANDI + ADT vs. 4 months for ADT alone.
Progression was defined as the cancer getting worse, as measured by scans, or if the patient died for any reason.
XTANDI was studied in men with advanced prostate cancer that:
- No longer responded to hormone therapy or surgical treatment to lower testosterone
- Had spread to other parts of the body
This study included 1,717 men. It compared men taking XTANDI with men not taking XTANDI.
These men had not received chemotherapy. All men either had surgery to lower testosterone or continued to take hormone therapy during the study.
In this same study, XTANDI helped men live longer.
The following numbers are the median.
*The median is not the average but the middle of a set of numbers.
(months)
(months)
The median overall survival was 35 months for men taking XTANDI + ADT vs. 31 months for ADT alone.
In addition, XTANDI delayed the median time before men began chemotherapy.
The following numbers are the median.
*The median is not the average but the middle of a set of numbers.
(months)
XTANDI (months)
During the study, XTANDI delayed the median time before men began chemotherapy: 28 months for men taking XTANDI compared with 11 months for men not taking XTANDI.
Results may vary. Talk with your doctor about what this may mean for you.
Select Safety Information
XTANDI may cause serious side effects including falls and fractures. XTANDI treatment may increase your risk for falls and fractures. Falls were not caused by loss of consciousness or seizures. Your doctor will monitor your risks for falls and fractures during treatment with XTANDI.
Non-metastatic castration-resistant prostate cancer (nmCRPC)
XTANDI slowed advanced prostate cancer progression.
Men taking XTANDI had a 71% lower chance of their cancer spreading compared with men not taking XTANDI during the study.
The median length of time until the cancer spread was 37 months for XTANDI + ADT vs. 15 months for ADT alone.
Progression was defined as the cancer spreading, as measured by scans, or if the patient died for any reason.
XTANDI was studied in men with prostate cancer that:
- No longer responded to hormone therapy or surgical treatment to lower testosterone
- Had not spread to other parts of the body
This study included 1,401 men. It compared men taking XTANDI with men not taking XTANDI.
These men had not received chemotherapy. All men either had surgery to lower testosterone or continued to take hormone therapy during the study.
In this same study, XTANDI helped men live longer.
The following numbers are the median.
*The median is not the average but the middle of a set of numbers.
(months)
(months)
The median overall survival was 67 months for men taking XTANDI vs. 56 months for ADT alone.
Results may vary. Talk with your doctor about what this may mean for you.
*The median is not the average but the middle of a set of numbers.
**ADT= Androgen Deprivation Therapy.
Select Safety Information
XTANDI may cause serious side effects including allergic reactions. Allergic reactions have happened in people who take XTANDI. Stop taking XTANDI and get medical help right away if you develop swelling of the face, tongue, lip or throat.
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