Astellas Introduces New Option for Men Living with Advanced Prostate Cancer

Astellas Introduces New Option for Men Living with Advanced Prostate Cancer 
Health Canada Approves Xtandi™, a New Androgen Receptor Inhibitor 
MARKHAM, ON, June 13, 2013 /CNW/ - Xtandi™ (enzalutamide capsules) is now 
available in Canada. On May 30, 2013, Health Canada approved Xtandi for the 
treatment of patients with metastatic castration-resistant prostate cancer, or 
mCRPC, who have received prior docetaxel therapy (chemotherapy medication).(1) 
The announcement was made today by Astellas Pharma Canada, Inc., the Canadian 
subsidiary of Tokyo-based Astellas Pharma, Inc. 
Prostate cancer is the most common cancer to affect Canadian men, generally 40 
years of age and older, with one in seven developing the disease in their 
lifetime.(2) Most often, initial presentation of the disease may be 
asymptomatic or show minimal symptoms.(3) However, approximately 10-20 per 
cent of cases will present with metastatic disease and another 33 per cent 
with early stage disease will go on to develop metastatic disease.(4) 
Castration-resistant prostate cancer (CRPC) is an advanced form of prostate 
cancer where the cancer progresses despite an initial response to hormonal 
therapy that lowers testosterone known as androgen depletion therapy (ADT).(5) 
Approximately 90 per cent of prostate cancer patients develop bone metastases 
causing significant morbidities, such as pain, pathologic fractures, spinal 
cord compression and bone marrow failure.(5) Sadly, CRPC is eventually 
"Men living with advanced prostate cancer and their families experience a 
burden that many of us will never be able to fully understand," says Jackie 
Manthorne, President and CEO, Canadian Cancer Survivor Network (CCSN). "The 
physical symptoms of the disease, such as pain, mean that not only are these 
men facing a terminal disease, but they may also be robbed of their quality of 
life and the ability to fully enjoy the time they have left with their loved 
Docetaxel therapy in combination with prednisone is the current standard of 
care for men with mCRPC.(5 )Once a patient's disease has progressed after 
docetaxel treatment, other treatment options include either chemotherapy, 
other new hormonal treatments or participation in a clinical trial. 
Xtandi, a new hormonal therapy, is now available in Canada. It is an androgen 
receptor inhibitor that works by blocking the activity of androgens (like 
testosterone) at the level of the androgen receptor, slowing or stopping the 
growth of prostate cancer, which may result in tumour shrinkage.(1,6) 
"In its early stages, patients can be successfully treated for prostate cancer 
and often cured. Yet for those patients whose disease continues to progress to 
the later stages, achieving optimal treatment outcomes is much more 
challenging therefore, ongoing research is crucial," says Dr. Kim N. Chi, a 
medical oncologist and prostate cancer researcher at the BC Cancer Agency. 
"Patients with mCRPC often progress quickly.New therapies such 
asenzalutamide provide the medical community with an importantoption for 
treating metastatic disease." 
About Xtandi
The efficacy and safety of Xtandi were assessed in a randomized, 
placebo-controlled, multinational phase III clinical trial, called AFFIRM, 
that included eleven Canadian trial sites across the country in Kelowna, 
Vancouver, Victoria, Calgary, Edmonton, London, Hamilton, Toronto, Montreal, 
Quebec City, and Halifax. A total of 1,199 patients with mCRPC who had 
previously received docetaxel were randomized 2:1 to receive either Xtandi 
orally at a dose of 160 mg once daily (N = 800) or placebo (N = 399). Patients 
with a history of seizure, taking medications known to decrease the seizure 
threshold, or with other risk factors for seizure were excluded from the 
clinical trial. The primary endpoint of the trial was overall survival.(6) 
"Astellas is committed to addressing the unmet medical needs of patients with 
advanced prostate cancer," says Michael Tremblay, President, Astellas Pharma 
Canada, Inc. "Metastatic castration-resistant prostate cancer is a devastating 
illness that can present many treatment challenges. With the availability of 
Xtandi, Canadian physicians and their patients have an important new option." 
About Astellas Pharma Canada, Inc.
Astellas Pharma Canada, Inc., headquartered in Markham, ON, is a Canadian 
affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical 
company dedicated to improving the health of people around the world through 
the provision of innovative and reliable pharmaceutical products. The 
organization is committed to becoming a global category leader in focused 
areas by combining outstanding R&D and marketing capabilities. In Canada, 
Astellas has an intense commercial focus on five therapeutic areas - Urology, 
Immunology, Infectious Disease, Dermatology and Oncology. For more information 
about Astellas Pharma Canada, Inc., please visit the corporate website: 
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(1) Xtandi Canadian Product Monograph 2013.
(2) Canadian Cancer Society. Canadian Cancer Statistics 2011.
Accessed April 2013.
(3) Public Health Agency of Canada. Prostate Cancer.
. Accessed March 2013.
(4) Bellmunt J, Carles J, Albanell J. Predictive modelling in 
hormone-refractory prostate cancer (HRPC). Clin Transl Oncol. 2009 
(5) Saad, F., et al. Guidelines for the management of castrate-resistant 
prostate cancer. Can Urol Assoc J 2010;4(6):380-4.
(6) Scher, H., et al. Increased Survival with Enzalutamide in Prostate Cancer 
after Chemotherapy. N Engl J Med 2012; 367:1187-1197. 
Stephanie Fitch energi PR 416-425-9143 ext. 17 
SOURCE: Astellas Pharma Canada, Inc. 
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