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
  • OR

  • has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone

It is not known if XTANDI is safe and effective in females or children.

Dennis, a real patient on XTANDI.
XTANDI® (enzalutamide) patient; Dennis

How XTANDI was studied

XTANDI is FDA-approved to treat 3 forms of advanced prostate cancer.

In all 3 forms, XTANDI helped slow
advanced prostate cancer progression.

Non-metastatic castration-resistant prostate cancer (nmCRPC)
71%
LOWER
CHANCE

XTANDI slowed advanced prostate cancer progression

Men taking XTANDI had a 71% lower chance of their cancer progressing compared with men not taking XTANDI during the study.

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 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.

Results may vary. Talk with your doctor about what this may mean for you.

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.

NEW
Metastatic castration-sensitive prostate cancer (mCSPC)
61%
LOWER
CHANCE

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.

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

  • 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, men taking XTANDI had a 72% lower chance of needing to begin new chemotherapy or other cancer drugs than 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 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)
83%
LOWER
CHANCE

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.

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.

35 MONTHS
31 MONTHS

The median overall survival was 35 months for men taking XTANDI vs 31 months for men not taking XTANDI.

 

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.

28 MONTHS
11 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.

Important Safety Information

Important Safety Information and Indication

What is XTANDI?

XTANDI is a prescription medicine used to treat men with prostate cancer that:

It is not known if XTANDI is safe and effective in females or children.

Important Safety Information

What should I tell my doctor before taking XTANDI?

Tell your doctor about all your medical conditions, including if you:

How should I take XTANDI?

What are the possible side effects of XTANDI?

XTANDI may cause serious side effects including:

Your doctor will stop treatment with XTANDI if you have serious side effects.

The most common side effects of XTANDI include:

XTANDI may cause fertility problems in males, which may affect the ability to father children. Talk to your doctor if you have concerns about fertility.

These are not all the possible side effects of XTANDI. For more information, talk to your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For further information, please talk to your doctor and click here for Patient Information and Full Prescribing Information for XTANDI.

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