Health Canada expands indication for ZYTIGA®* in men with metastatic prostate cancer

~New indication provides physicians with option to be used earlier in treatment of the disease, with hope of delaying chemotherapy~

TORONTO, May 29, 2013 /CNW/ - Janssen Inc. announced today that Health Canada has approved the once-daily, oral medication ZYTIGA^® (abiraterone acetate), for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT).¹ Until today, there have been limited treatment options prior to chemotherapy for men with mCRPC. The approval expands the indication for ZYTIGA^®, which Health Canada approved in July 2011 for use in combination with prednisone for the treatment of men with mCRPC who have received prior chemotherapy containing docetaxel after failure of ADT.

"This expanded indication for ZYTIGA^® is exciting news for men living with metastatic prostate cancer as it provides them with a proven treatment option after failure of androgen deprivation therapy, where there continues to be a need for additional treatment options," says Dr. Neil Fleshner, head of urology, University Health Network. "I believe the availability of this treatment earlier in the disease will offer patients delayed disease progression, improved quality of life and an improvement in survival time."

ZYTIGA^® selectively inhibits the enzyme complex that is required for the production of androgens. Androgens are hormones that promote the development and maintenance of male sex characteristics; however, in prostate cancer androgens can work to fuel tumour growth.

The Health Canada approval is based on analyses of a Phase 3, randomized, double-blind, placebo-controlled international clinical study that demonstrated a statistically significant improvement in radiographic Progression-Free Survival (rPFS) in the ZYTIGA^® plus prednisone arm of the study compared to the placebo plus prednisone (control) arm. Treatment with ZYTIGA^® decreased the risk of radiographic progression or death by 57 per cent compared to placebo.² The median rPFS in the control arm was 8.28 months but had not yet been reached in the ZYTIGA^® arm because progression events were occurring more slowly in the ZYTIGA^® arm compared to the control arm.

In a separate pre-specified interim analysis, Overall Survival (OS) was longer for the ZYTIGA^® arm compared to the control arm with a 25 per cent decrease in the risk of death in the ZYTIGA^® group, indicating a strong trend toward improved survival with ZYTIGA^®.³ Additional data from this same interim analysis, recently published in the New England Journal of Medicine, indicate a median time to rPFS on the basis of investigator assessment was 16.5 months in the ZYTIGA^® plus prednisone group and 8.3 months in the prednisone alone group.⁴

"This is great news for Canadian men living with advanced prostate cancer. This new treatment option can provide them with choices that will lead to better quality of life during the later stages of the disease," says Jackie Manthorne, President and CEO, Canadian Cancer Survivor Network. "Men and their caregivers understand that metastatic prostate cancer progresses over time, and during its progression, it is important to continue enjoying life to the fullest extent possible."

About the COU-AA-302 Study

COU-AA-302 is an international, randomized, double-blind, placebo controlled Phase 3 study that included 1,088 men, including 100 Canadians, with mCRPC who had not received prior chemotherapy, who were randomized to receive ZYTIGA^® 1,000 milligrams (mg) administered orally once daily plus prednisone five mg administered twice daily or placebo plus prednisone five mg administered twice daily. The co-primary endpoints of the study are rPFS and OS. Delay in chemotherapy, delay in prostate-specific antigen (PSA) progression, improved performance status (general well-being and activities of daily life) and pain progression were secondary endpoints and showed favourable outcomes for ZYTIGA^® plus prednisone consistently and statistically across all measures.⁵

The most common all grade adverse reactions observed with ZYTIGA^® compared to the control arm were joint pain or discomfort (32 per cent vs. 27 per cent), peripheral edema (25 per cent vs. 20 per cent), hot flush (22 per cent vs. 18 per cent), diarrhea (22 per cent vs. 18 per cent), hypertension (22 per cent vs. 13 per cent), cough (17 per cent vs. 14 per cent), hypokalemia (17 per cent vs. 13 per cent), upper respiratory tract infection (13 per cent vs. 8 per cent), dyspepsia (11 per cent vs. 5 per cent), hematuria (10 per cent vs. 6 per cent), nasopharyngitis (11 per cent vs. 8 per cent), vomiting (13 per cent vs. 11 per cent), fatigue (39 per cent vs. 34 per cent), constipation (23 per cent vs. 19 per cent), contusion (13 per cent vs. 9 per cent), insomnia (14 per cent vs. 11 per cent), anemia (11 per cent vs. 9 per cent) and dyspnea (12 per cent vs. 10 per cent).⁶

About ZYTIGA® (abiraterone acetate)

ZYTIGA^® is an oral medication for prostate cancer. In July 2011, ZYTIGA^® was approved by Health Canada with prednisone for the treatment of men with mCRPC who have received prior chemotherapy containing docetaxel after failure of ADT.

ZYTIGA^® was the first oral treatment that inhibits androgen production at all three sources - the testes, adrenal glands and in the tumour itself.

About Metastatic Prostate Cancer in Canada

Metastatic prostate cancer occurs when cancer has spread beyond the prostate and disease progresses despite serum testosterone below castrate levels.

Prostate cancer is the most common cancer to afflict men in Canada and approximately 26,500 men are diagnosed with prostate cancer annually.⁷ According to the Canadian Cancer Society, prostate cancer is turning up in men in their 40s and on average, 73 Canadian men are diagnosed with prostate cancer every day, and 11 men die of prostate cancer every day.⁸  If prostate cancer is detected and treated early, it can be cured. Fortunately, death rates have been declining since the mid-1990s.⁹

About Janssen Inc.

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases and women's health.  Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world.  Janssen Inc. is a member of the Janssen Pharmaceutical Companies.  Please visit www.janssen.ca for more information.

*All trademark rights used under license.

References
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¹ ZYTIGA® Canadian Product Monograph. Page 3. May 28, 2013.

² ZYTIGA® Canadian Product Monograph. Page 23. May 28, 2013.

³ ZYTIGA® Canadian Product Monograph. Page 25. May 28, 2013.

⁴ Ryan C, Smith M, de Bono J et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med 2013;368:138-148.

⁵ ZYTIGA® Canadian Product Monograph. Page 27. May 28, 2013.

⁶ ZYTIGA® Canadian Product Monograph. Page 7. May 28, 2013.

⁷ Canadian Cancer Society.  Prostate Cancer Statistics at a glance.  Available at: http://www.cancer.ca/Canada-wide/About%20cancer/Cancer%20statistics/Stats%20at%20a%20glance/Prostate%20cancer.aspx?sc_lang=en. Last accessed March 13, 2013.

⁸ Ibid.

⁹ Ibid.

SOURCE Janssen Inc.