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."
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:
NOTES TO EDITOR
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(1) Xtandi Canadian Product Monograph 2013.
(2) Canadian Cancer Society. Canadian Cancer Statistics 2011. cancer.ca.
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 Stephanie.email@example.com
SOURCE: Astellas Pharma Canada, Inc.
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