In multiple clinical studies, XTANDI was proven to delay cancer progression and helped men live longer.

Metastatic castration-sensitive prostate cancer (mCSPC)

Prostate cancer that has spread to other parts of the body and responds to hormone therapy or surgical treatment to lower testosterone.

Five-year overall survival outcomes data available

XTANDI was studied among 1,150 men with prostate cancer that had spread to other parts of the body and was still responding to hormone therapy or surgery to lower testosterone.

These men were divided into two groups:

574 received XTANDI + ADT (androgen deprivation therapy)
576 received ADT alone

During the study, all men continued ADT, either hormone therapy or surgery to lower testosterone.

XTANDI slowed disease progression

Men who took XTANDI + ADT had 61% less risk of their cancer progressing compared to those who took ADT alone.

This means the study found the XTANDI + ADT group had 61% less risk of cancer progressing.*

At the time of analysis, progression was seen in 89 out of 576 (16%) men in the XTANDI group, compared to 198 out of 574 (34%) men in the ADT-alone group.

Patients whose cancer progressed

XTANDI + ADT

16 %

ADT ALONE

34 %

^*Progression was defined as the cancer getting worse, as measured by scans, or if the patient died for any reason.

The median length of time until the cancer got worse was not reached for patients taking XTANDI + ADT because more than half of the men were still alive. As opposed, the median length of time until the cancer got worse was 19 months with ADT alone. The median is not the average, but the middle of a set of numbers.

In the same study, XTANDI helped men live longer (Overall Survival)

Men taking XTANDI had a 34% reduction in the risk of death compared with men not taking XTANDI.

This means the study found the XTANDI + ADT group had a 34% reduction in the risk of death compared with men not taking XTANDI.

At the time of analysis, there were 154 out of 574 (27%) deaths in the XTANDI group, compared with 202 out of 576 (35%) deaths in the ADT-alone group.

Patients who experienced a fatal event

XTANDI + ADT

27 %

ADT ALONE

35 %

The median length of time patients lived after starting treatment was not reached for either treatment arm. The median is not the average, but the middle of a set of numbers.

In addition, patients receiving XTANDI had a 72% improvement in delaying the time before receiving the next cancer treatment, including chemo, compared with ADT alone.

Five-year follow-up on overall survival data

Investigators observed the number of patients who were alive around 5 years after patients started their treatment in the study. The study above was not designed to show a difference between the two treatment groups at 5 years. This means that these observations cannot tell us if there are differences in the results because of the treatment patients in each group received. Conclusions cannot be reached on this data, including which treatment is better or worse.

Unlike the main analysis shown above, the data did not undergo an additional independent review, and it was not used to support the FDA approval of XTANDI. Please speak with your doctor to better understand what this means for you.

Number of patients alive at 5 years

XTANDI + ADT

191 deaths out of 574 men

ADT ALONE

223 deaths out of 576 men

Results may vary. Always talk with your doctor to best understand clinical data.

Select Safety Information

XTANDI may cause serious side effects including: seizure, a brain condition called PRES, allergic reactions, heart disease that can lead to death, falls and bone fractures, swallowing problems or choking that can lead to death. Learn more about possible side effects

Metastatic castration-resistant prostate cancer (mCRPC)

Prostate cancer that has spread to other parts of the body and no longer responds to a hormone therapy or surgical treatment to lower testosterone.

XTANDI was studied in 1,717 men with prostate cancer that had spread to other parts of the body and no longer responded to hormone therapy or surgical treatment to lower testosterone.

These men were divided into two groups:

872 received XTANDI + ADT (androgen deprivation therapy)
845 received ADT alone

During the study, all men continued ADT, either hormone therapy or surgery to lower testosterone.

XTANDI slowed disease progression

Men taking XTANDI had an 83% lower chance of their cancer progressing compared with men not taking XTANDI.

This means the study found the XTANDI + ADT group had 83% less risk of cancer progressing.*

At the time of analysis, progression was seen in 118 out of 832 (14%) men in the XTANDI group, compared with 320 out of 801 (40%) men in the ADT-alone group.

Patients whose cancer progressed

XTANDI + ADT

14 %

ADT ALONE

40 %

^*Progression was defined as the cancer getting worse, as measured by scans, or if the patient died for any reason.

The median length of time until the cancer got worse was not reached for XTANDI + ADT vs. 4 months for ADT alone. The median is not the average, but the middle of a set of numbers.

In the same study, XTANDI helped men live longer (Overall Survival)

Men taking XTANDI had a 23% reduction in the risk of death compared with men not taking XTANDI.

This means the study found the XTANDI + ADT group had a 23% reduction in the risk of death compared with men not taking XTANDI.

At the time of analysis, there were 368 out of 872 (42%) deaths in the XTANDI group, compared with 416 out of 845 (49%) deaths in the ADT-alone group.

Patients who experienced a fatal event

XTANDI + ADT

42 %

ADT ALONE

49 %

The median overall survival was 35 months for men taking XTANDI + ADT vs. 31 months for ADT alone. The median is not the average, but the middle of a set of numbers.

65% reduction in starting new chemotherapy

In addition, men taking XTANDI had a 65% reduction in risk of starting new chemotherapy and also delayed the median time before beginning chemotherapy.

The median time before beginning chemotherapy was 28 months for men taking XTANDI + ADT vs. 11 months for ADT alone. The median is not the average, but the middle of a set of numbers.

Results may vary. Always talk with your doctor to best understand clinical data.

Select Safety Information

Non-metastatic castration-resistant prostate cancer (nmCRPC)

Prostate cancer that has not spread to other parts of the body and no longer responds to a hormone therapy or surgical treatment to lower testosterone.

XTANDI was studied in 1,401 men with prostate cancer that had not spread to other parts of the body and no longer responded to hormone therapy or surgical treatment to lower testosterone.

These men were divided into two groups:

933 received XTANDI + ADT (androgen deprivation therapy)
468 received ADT alone

During the study, all men continued ADT, either hormone therapy or surgery to lower testosterone.

XTANDI slowed disease spread

Men taking XTANDI had 71% less risk of their cancer spreading compared with men not taking XTANDI.

This means the study found the XTANDI + ADT group had 71% less risk of cancer spreading.*

At the time of analysis, cancer spreading was seen in 219 out of 933 (24%) men in the XTANDI group, compared with 228 out of 468 (49%) men in the ADT-alone group.

PATIENTS WHOSE CANCER SPREAD

XTANDI + ADT

24 %

ADT ALONE

49 %

^*Cancer was considered to be spreading if shown by scans or if the patient died for any reason.

The median length of time until the cancer spread was 37 months for XTANDI + ADT vs. 15 months for ADT alone. The median is not the average, but the middle of a set of numbers.

In the same study, XTANDI helped men live longer (Overall Survival)

Men taking XTANDI had a 27% reduction in the risk of death compared with men not taking XTANDI.

This means the study found the XTANDI + ADT group had a 27% reduction in the risk of death compared with men not taking XTANDI.

At the time of analysis, there were 288 out of 933 (31%) deaths in the XTANDI group, compared to 178 out of 468 (38%) deaths in the ADT-alone group.

Patients who experienced a fatal event

XTANDI + ADT

31 %

ADT ALONE

38 %

The median overall survival was 67 months for men taking XTANDI + ADT vs. 56 months for ADT alone. The median is not the average, but the middle of a set of numbers.

In addition, men taking XTANDI had a 79% reduction in risk of starting their next cancer treatment, including chemo. XTANDI also delayed the median time before men began chemotherapy.

The median time before beginning chemotherapy was 40 months for men taking XTANDI + ADT vs. 18 months for ADT alone. The median is not the average, but the middle of a set of numbers.

Results may vary. Always talk with your doctor to best understand clinical data.

Select Safety Information

Non-metastatic castration-sensitive prostate cancer (nmCSPC) with high risk of cancer spreading

Prostate cancer in men that has not spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone, and who are at a high risk of cancer spreading to other parts of the body.

XTANDI was studied in 1,068 men with prostate cancer:

That had not spread to other parts of the body and responds to a hormone therapy to lower testosterone
Who are at high risk of cancer spreading to other parts of the body
Who had not received chemotherapy and who all had prior surgery or radiation as definitive treatment

These men were divided into three groups:

355 received XTANDI + ADT (androgen deprivation therapy)
355 received XTANDI alone
358 received ADT alone

The median length of time until the cancer spread was not reached for any treatment arm. Cancer was considered to be spreading if shown 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 + ADT slowed disease progression

Men taking XTANDI + ADT had a 58% lower chance of their cancer spreading compared with men taking ADT alone.

This means the study found the XTANDI + ADT group had 58% less risk of cancer spreading.*

At the time of analysis, cancer spreading was seen in 45 out of 355 (13%) men in the XTANDI + ADT group, compared with 92 out of 358 (26%) men in the ADT-alone group.

PATIENTS WHOSE CANCER SPREAD

XTANDI + ADT

13 %

ADT ALONE

26 %

XTANDI alone slowed disease progression

Men taking XTANDI alone had a 37% lower chance of their cancer spreading compared with men taking ADT alone.

This means the study found the XTANDI group had 37% less risk of cancer spreading.

At the time of analysis, cancer spreading was seen in 63 out of 355 (18%) men in the XTANDI + ADT group, compared with 92 out of 358 (26%) men in the ADT-alone group.

PATIENTS WHOSE CANCER SPREAD

XTANDI

18 %

ADT ALONE

26 %

This trial is ongoing to determine the effect on overall survival.

A medication holiday may be recommended by your doctor. This means you may take a break from your treatment. The length of your break will be determined by your doctor.

^*Cancer was considered to be spreading if shown by scans or if the patient died for any reason.

The median length of time until the cancer spread was not reached for any treatment arm. The median is not the average, but the middle of a set of numbers.

Results may vary. Always talk with your doctor to best understand clinical data.

Select Safety Information

Discover more XTANDI resources

Real people, real stories

Hear firsthand from men who are taking XTANDI

Watch their stories

Doctor discussion guide

Need to prepare for your next doctor’s visit?

Review the guide

Possible side effects

Learn what they are and when to talk to your doctor

Know the signs

What should I tell my doctor before taking XTANDI?

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

Have a history of seizures, brain injury, stroke, or brain tumors.
Have a history of heart disease, have high blood pressure, or have abnormal amounts of fat or cholesterol in your blood (dyslipidemia).
Are pregnant or plan to become pregnant. XTANDI can cause harm to your unborn baby and loss of pregnancy (miscarriage).
Have a partner who is pregnant or may become pregnant.
- Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment with XTANDI and for 3 months after the last dose.
- Males must use a condom during sex with a pregnant female.
Are breastfeeding or plan to breastfeed. It is not known if XTANDI passes into your breast milk.
Take other medicines. XTANDI may affect the way other medicines work, and other medicines may affect how XTANDI works. These include prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not start or stop any medicine without talking to your doctor.

How should I take XTANDI?

Take XTANDI exactly as your doctor tells you. Take your prescribed dose once a day, at the same time each day. XTANDI can be taken with or without food. Swallow XTANDI capsules or tablets whole with enough water to make sure that you can swallow all of the medicine successfully. Do not chew, dissolve, or open the capsules. Do not cut, crush or chew the tablets. Your doctor may change your dose if needed. Your doctor may also change your pill size or stop treatment if you have swallowing problems.
Do not change or stop taking your prescribed dose of XTANDI without talking with your doctor first.
If you are receiving gonadotropin-releasing hormone (GnRH) therapy, you should continue with this treatment while taking XTANDI unless you have had surgery to lower the amount of testosterone in your body (surgical castration).
If you miss a dose of XTANDI: Take your prescribed dose as soon as you remember that day. If you miss your daily dose, take your prescribed dose at your regular time the next day. Do not take more than your prescribed dose of XTANDI each day.
If you take too much XTANDI: Call your doctor or go to the nearest emergency room right away. You may have an increased risk of seizure if you take too much XTANDI.

What are the possible side effects of XTANDI?

XTANDI may cause serious side effects including:

Seizure. If you take XTANDI, you may be at risk of having a seizure. Avoid activities where a sudden loss of consciousness could seriously harm you or someone else. Tell your doctor right away if you lose consciousness or have a seizure.
Posterior Reversible Encephalopathy Syndrome (PRES). If you take XTANDI you may be at risk of developing a condition involving the brain called PRES. Tell your doctor right away if you have a seizure or quickly worsening symptoms such as headache, decreased alertness, confusion, reduced eyesight, blurred vision or other visual problems. Your doctor will do a test to check for PRES.
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.
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.
Falls and Bone Fractures. XTANDI treatment may increase your risk for falls and bone fractures. Falls were not caused by loss of consciousness or seizures. Your doctor will monitor your risks for falls and bone fractures during treatment with XTANDI.
Swallowing Problems or Choking. Severe swallowing problems or choking, including life-threatening problems or death can happen in people during treatment with XTANDI, because of the size of the XTANDI capsules and tablets. Swallow each XTANDI capsule or tablet whole with enough water to make sure that you can swallow all of the medicine successfully.

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

The most common side effects of XTANDI include:

Muscle and joint pain
Feeling more tired than usual
Hot flashes
Constipation
Decreased appetite
Diarrhea
High blood pressure
Bleeding problems
Falls
Bone fractures
Headache

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.

What is XTANDI?

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
OR
has not spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone, and who are at high risk of cancer spreading to other parts of the body.

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

XTANDI is FDA-approved to treat 4 types of advanced prostate cancer

In multiple clinical studies, XTANDI was proven to delay cancer progression and helped men live longer.

Metastatic castration-sensitive prostate cancer (mCSPC)

XTANDI slowed disease progression

Men who took XTANDI + ADT had 61% less risk of their cancer progressing compared to those who took ADT alone.

XTANDI + ADT

ADT ALONE

In the same study, XTANDI helped men live longer (Overall Survival)

Men taking XTANDI had a 34% reduction in the risk of death compared with men not taking XTANDI.

XTANDI + ADT

ADT ALONE

In addition, patients receiving XTANDI had a 72% improvement in delaying the time before receiving the next cancer treatment, including chemo, compared with ADT alone.

Number of patients alive at 5 years

Select Safety Information

Metastatic castration-resistant prostate cancer (mCRPC)

XTANDI slowed disease progression

Men taking XTANDI had an 83% lower chance of their cancer progressing compared with men not taking XTANDI.

XTANDI + ADT

ADT ALONE

In the same study, XTANDI helped men live longer (Overall Survival)

Men taking XTANDI had a 23% reduction in the risk of death compared with men not taking XTANDI.

XTANDI + ADT

ADT ALONE

In addition, men taking XTANDI had a 65% reduction in risk of starting new chemotherapy and also delayed the median time before beginning chemotherapy.

Select Safety Information

Non-metastatic castration-resistant prostate cancer (nmCRPC)

XTANDI slowed disease spread

Men taking XTANDI had 71% less risk of their cancer spreading compared with men not taking XTANDI.

XTANDI + ADT

ADT ALONE

In the same study, XTANDI helped men live longer (Overall Survival)

Men taking XTANDI had a 27% reduction in the risk of death compared with men not taking XTANDI.

XTANDI + ADT

ADT ALONE

In addition, men taking XTANDI had a 79% reduction in risk of starting their next cancer treatment, including chemo. XTANDI also delayed the median time before men began chemotherapy.

Select Safety Information

Non-metastatic castration-sensitive prostate cancer (nmCSPC) with high risk of cancer spreading

XTANDI + ADT slowed disease progression

Men taking XTANDI + ADT had a 58% lower chance of their cancer spreading compared with men taking ADT alone.

XTANDI + ADT

ADT ALONE

XTANDI alone slowed disease progression

Men taking XTANDI alone had a 37% lower chance of their cancer spreading compared with men taking ADT alone.

XTANDI

ADT ALONE

Select Safety Information

Discover more XTANDI resources

Real people, real stories

Doctor discussion guide

Possible side effects

What should I tell my doctor before taking XTANDI?

How should I take XTANDI?

What are the possible side effects of XTANDI?

The most common side effects of XTANDI include:

What is XTANDI?