Why ZYTIGA®?
(abiraterone acetate)

ZYTIGA® Was Studied In Two Clinical Trials

 

In a Clinical Trial of Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Had Not Received Prior Chemotherapy:

In a clinical study of 1,088 men with mCRPC whose disease progressed while on  therapy (ADT)1 and who had not received prior chemotherapy:

Certain men who received ZYTIGA® plus prednisone lived longer than men who received placebo plus prednisone.

The  was 34.7 months for the group of men who received ZYTIGA® plus prednisone, compared to 30.3 months for the group of men who received placebo plus prednisone. Please speak to your doctor about what this may mean to you.

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References:

1Androgen deprivation—A treatment to suppress or block the production or action of male hormones. (National Cancer Institute: NCI Dictionary of Cancer Terms. Bethesda, MD: National Cancer Institute. 2013. Available at www.cancer.gov/dictionary. Accessed 5/13/2016.)

2Placebo—An inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested. (National Cancer Institute: NCI Dictionary of Cancer Terms. Bethesda, MD: National Cancer Institute. 2013. Available at www.cancer.gov/dictionary. Accessed 5/13/2016.)

3Median overall survival—the length of time from either the date of diagnosis or the start of a clinical study or treatment for a disease, such as cancer, that half of the patients in a group of patients diagnosed with the disease are still alive. In a clinical trial, measuring the median overall survival is one way to see how well a new treatment works. Also called median survival.(National Cancer Institute: NCI Dictionary of Cancer Terms. Bethesda, MD: National Cancer Institute. 2013. Available at www.cancer.gov/dictionary. Accessed 5/13/2016.)

In the same study, at a planned analysis, fewer men had progression as measured by imaging studies in the group who received ZYTIGA® plus prednisone compared to the group who received placebo plus prednisone.

In the group of men who received ZYTIGA® plus prednisone, the median length of time they lived with the disease and it did not get worse was longer, as measured by imaging studies, compared to the group of men who received placebo plus prednisone.

  • 65% (354 of 546) of men who received ZYTIGA® plus prednisone had progression, as measured by imaging studies.

  • 71% (387 of 542) of men who received placebo plus prednisone had progression, as measured by imaging studies.

Please speak to your doctor about what this may mean to you.

The most common side effects of ZYTIGA® include:

  • Weakness

  • Joint swelling or pain

  • Swelling in your legs or feet

  • Hot flushes

  • Diarrhea

  • Vomiting

  • Cough

  • High blood pressure

  • Shortness of breath

  • Urinary tract infection

  • Bruising

  • Low red blood cells (anemia) and low blood potassium levels

  • High blood sugar levels, high blood cholesterol and triglycerides

  • Certain other abnormal blood tests

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

In the same study, ZYTIGA® plus prednisone delayed the start of chemotherapy compared to placebo plus prednisone in certain men.

In the group of men who received ZYTIGA® plus prednisone, the median time to starting chemotherapy was 25.2 months compared to 16.8 months for the group of men who received placebo plus prednisone.

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In a Trial of Men with Metastatic Castration-Resistant Prostate Cancer Who Received Prior Chemotherapy with Docetaxel:

In another study of 1,195 men with mCRPC who had received chemotherapy with docetaxel:

Certain men who received ZYTIGA® plus prednisone lived longer than those who received placebo plus prednisone.

Certain men with mCRPC who had already received chemotherapy with docetaxel who received ZYTIGA® plus prednisone lived significantly longer than those who received placebo plus prednisone. In the updated analysis of the clinical trial, the median overall survival for men who received ZYTIGA® plus prednisone was 15.8 months, versus 11.2 months for men who received placebo plus prednisone. The primary analysis had shown that the median overall survival for men who received ZYTIGA® plus prednisone was 14.8 months, versus 10.9 months for men who received placebo plus prednisone.

Talk with your doctor to see if ZYTIGA® is right for you.