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About ERLEADA® | ERLEADA® (apalutamide)

ABOUT ERLEADA® (apalutamide)

ERLEADA® + ADTi work together to lower androgensi
that can help fuel prostate cancer

Study results in mCSPCi

ERLEADA® + ADT was compared with placeboi + ADT in a clinical study of 1052 men with mCSPC

mCSPC is prostate cancer that HAS SPREAD to other parts of the body and STILL responds to medical or surgical treatment that lowers testosterone

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In this study, men either received ERLEADA® 240 mg once daily or placebo. All men in the study received ADT

1052

ADT: Androgen deprivation therapy (ADT) includes medical or surgical treatment that lowers testosterone.

mCSPC: Metastatic castration-sensitive prostate cancer (mCSPC) is prostate cancer that HAS SPREAD to other parts of the body and STILL responds to medical or surgical treatment that lowers testosterone.

Placebo: Pronounced “pluh-see-bow”: a pill that looks like “real” medicine but contains nothing to affect health.

Being there longer is possible™

You may live longer with ERLEADA®

In a clinical study, ERLEADA® + ADT reduced the risk of death by 35% vs placebo + ADT*

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Median (middle) follow-up time was 44.0 months.

In an earlier analysis from the study, the reduction in the risk of death was 33%.

Here’s another way to look at the results:

At 4 years, approximately 65% of men taking ERLEADA® + ADT were alive vs 52% of men taking placebo + ADT*

*Median (middle) data has not been reached for ERLEADA®.

In a clinical study, ERLEADA® + ADT reduced the risk of prostate cancer getting worse by 52% vs placebo + ADT

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Here’s another way to look at the results:

At 2 years, approximately 68% of men taking ERLEADA® + ADT lived without their disease getting worse vs 48% of men taking placebo + ADT

Median (middle) data has not been reached for ERLEADA®.

Additional study results in mCSPC

The clinical study for men with mCSPC also evaluated time to chemotherapyi

61 percent

Median (middle) data has not been reached.

ERLEADA® + ADT reduced the risk of beginning chemotherapy by 61% vs placebo + ADT

ADT: Androgen deprivation therapy (ADT) includes medical or surgical treatment that lowers testosterone.

Chemotherapy: Type of drug(s) that kill cancer cells.

Median: The middle number in a set of numbers. For 50% of people, this value was larger, and for 50% of people, it was smaller.

mCSPC: Metastatic castration-sensitive prostate cancer (mCSPC) is prostate cancer that HAS SPREAD to other parts of the body and STILL responds to medical or surgical treatment that lowers testosterone.

Placebo: Pronounced “pluh-see-bow”: a pill that looks like “real” medicine but contains nothing to affect health.

Progression: Disease spreading further as measured by imaging studies or dying.

Time to chemotherapy: Length of time from when patients began study to starting chemotherapy.

Study results in nmCRPCi

ERLEADA® + ADT was compared with placeboi + ADT in a clinical study of 1207 men with nmCRPC

nmCRPC is prostate cancer that HAS NOT SPREAD to other parts of the body and NO LONGER responds to a medical or surgical treatment that lowers testosterone

pill-icon

In this study, men either received ERLEADA® 240 mg once daily or placebo. All men in the study received ADT

1207-graphic-mobile

ADT: Androgen deprivation therapy (ADT) includes medical or surgical treatment that lowers testosterone.

nmCRPC: Non-metastatic castration-resistant prostate cancer (nmCRPC) is prostate cancer that HAS NOT SPREAD to other parts of the body and NO LONGER responds to medical or surgical treatment that lowers testosterone.

Placebo: Pronounced “pluh-see-bow”: a pill that looks like “real” medicine but contains nothing to affect health.

Being there longer is possible™

ERLEADA® helped some men with nmCRPC live longer without the spread of prostate cancer

In a clinical study,

ERLEADA® + ADT delayed the spread of cancer to other parts of the body or death by a mediani of 24.3 months compared with placebo + ADT

40.5months vs 16.2 months

Additional study results in nmCRPC

The clinical study for men with nmCRPC also evaluated:

Overall Survival: Living Longer

14-months-longer

Progression-Free Survivali
Delaying the Spread of Cancer

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Time to Chemotherapyi Delaying the Start of Chemotherapy

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ERLEADA® + ADT reduced the risk of beginning chemotherapy by 37% vs placebo + ADT§

§Median (middle) data has not been reached.

ADT: Androgen deprivation therapy (ADT) includes medical or surgical treatment that lowers testosterone.

Chemotherapy: Type of drug(s) that kill cancer cells.

Median: The middle number in a set of numbers. For 50% of people, this value was larger, and for 50% of people, it was smaller.

nmCRPC: Non-metastatic castration-resistant prostate cancer (nmCRPC) is prostate cancer that HAS NOT SPREAD to other parts of the body and NO LONGER responds to medical or surgical treatment that lowers testosterone.

Placebo: Pronounced “pluh-see-bow”: a pill that looks like “real” medicine but contains nothing to affect health.

Progression-free survival: Length of time patients lived without their prostate cancer spreading to local or distant parts of the body or death.

Time to chemotherapy: Length of time from when patients began study to starting chemotherapy.

Side effects

ERLEADA® may cause serious side effects including:

  • chest pain or discomfort at rest or with activity
  • shortness of breath
  • numbness or weakness of the face, arm, or leg, especially on one side of the body
  • trouble talking or understanding
  • trouble seeing in one or both eyes
  • dizziness, loss of balance or coordination, or trouble walking

The most common side effects of ERLEADA® include:

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Feeling very tired

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Joint pain

Rash

Rash.
Tell your healthcare provider if you get a rash.

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Decreased appetite

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Fall

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Weight loss

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Hypertension

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Hot flash

Diarrhea

Diarrhea

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Fracture

ERLEADA® may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. Do not donate sperm during treatment with ERLEADA® and for 3 months after the last dose of ERLEADA®.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ERLEADA®.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Personalized Support. From People Who Care.

Once you and your doctor have decided that ERLEADA® is right for you, you have access to a free, personalized support program that connects you with a dedicated Care Navigator to help you get started with your treatment and stay on track.

Your personal Care Navigator is just a phone call away.

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You can also call us at 844-NAV-1234 (844-628-1234),

Monday through Friday, 8:30 AM - 8:30 PM ET

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