Health Canada expands indication for ZYTIGA(R)* 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
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.
(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.
SOURCE Janssen Inc.