Approval represents a development for Canadian patients with hormone
receptor-positive (HR+), HER2-negative advanced breast cancer since
aromatase inhibitors were introduced almost 15 years ago1
In a landmark study of 724 patients randomized to receive either the
combination of AFINITOR* plus exemestane or placebo plus exemestane,
there was a statistically significant clinical benefit of AFINITOR*
plus exemestane by more than doubling median progression-free survival2
AFINITOR*, the first mTOR inhibitor approved for HR+, HER2-negative
advanced breast cancer, is given after the disease progresses following
prior therapy with letrozole or anastrozole2
DORVAL, QC, Jan. 16, 2013 /CNW/ - Novartis Canada today announced that Health Canada has approved AFINITOR* (everolimus) tablets for the treatment of
postmenopausal women with hormone receptor-positive, HER2-negative
advanced breast cancer in combination with exemestane after recurrence
or progression following treatment with letrozole or anastrozole.3
"Everolimus is the first in a new class of treatment to overcome
resistance to endocrine therapy," said Dr. Sunil Verma, Canadian
Medical Oncologist. "The approval of everolimus has the potential to
redefine the way we treat hormone receptor-positive advanced breast
cancer, and offers physicians and patients a new therapeutic option
where there remains a significant need."
In Canada, an estimated 22,700 women were diagnosed with breast cancer
in 2012.4 Of those newly diagnosed patients, approximately 10 per cent will have
locally advanced and/or metastatic disease and 20 to 85 per cent of
patients, depending on the initial stage, tumour biology, and treatment
strategy used, who are diagnosed with early breast cancer will later
develop recurrent and/or metastatic disease.5 Advanced breast cancer is currently considered an incurable disease. It
is estimated that women with metastatic breast cancer have a life
expectancy of approximately 18-36 months after diagnosis,6 and median survival for women with stage III disease is less than five
Diagnosed with metastatic breast cancer in 2012, Susan Cooper knows
first-hand what it's like to live with the disease.
"Advanced breast cancer has changed the way I look at life. Time is so
precious. I try to make the most of every day and not let my cancer
stop me from doing the things I love to do, like spending time with my
grandchildren," said Susan. "My hope is that new treatments will help
others live longer without their cancer getting worse, while allowing
them to enjoy the time they have left."
For women with HR+, HER2-negative advanced breast cancer, endocrine therapy remains the cornerstone of treatment,
but most will eventually develop resistance to this therapy.2 Approximately 50 per cent of HR+ breast cancer patients with metastatic
disease do not respond to initial treatment with hormone therapy, and
almost all initial responders develop resistance.8 This therapeutic resistance has been associated with overactivation of
the PI3K/AKT/mTOR pathway.2 AFINITOR* targets the mTOR pathway, which is dysregulated in the
majority of human cancers. mTOR is a protein that plays a central role
in the regulation of cell growth, proliferation and survival3.
"Women living with metastatic breast cancer have unique needs that
differ from those living with primary disease. In addition to
much-needed programs and services to support these women, access to new
treatments is crucial in battling this incurable, yet treatable, form
of breast cancer," said Cathy Ammendolea, Chair, Canadian Breast Cancer
About Advanced Breast Cancer
Hormone receptor-positive, HER2-negative advanced breast cancer (HR+,
HER2-negative advanced breast cancer) is comprised of metastatic breast
cancer (stage IV) and locally advanced breast cancer (stage III).9 Metastatic breast cancer is the most serious form of the disease and
occurs when the cancer has spread to other parts of the body, such as
the bones or liver.9 Locally advanced breast cancer occurs when the cancer has spread to
lymph nodes and/or other tissue in the area of the breast, but not to
distant sites in the body.10
HR+ breast cancer is characterized by hormone receptor tumours, a group
of cancers that express receptors for certain hormones, such as
estrogen and progesterone. Cancer cell growth can be driven by these
hormones.9 The presence of estrogen receptor (ER) and/or progesterone receptor
(PgR) is one of the most important predictive and prognostic markers in
human breast cancers, and is collectively referred to as hormone
AFINITOR* tablets are approved in more than 80 countries, including
Canada, for the treatment of well- or moderately differentiated
neuroendocrine tumours of pancreatic origin (PNET) in patients with
unresectable, locally advanced or metastatic disease that has
progressed within the last 12 months the treatment of patients with
metastatic renal cell carcinoma (RCC) of clear cell morphology, after
failure of initial treatment with either of the VEGF-receptor TKIs1
sunitinib or sorafenib. To date, approximately 45,500 patients have
been treated with everolimus worldwide across other approved
Health Canada approval of AFINITOR* in HR+, HER2-negative advanced
breast cancer was based on a randomized, double-blind, multi-center
Phase III study of AFINITOR* plus exemestane versus placebo plus
exemestane in postmenopausal women with estrogen receptor-positive,
HER2-neu/non-amplified breast cancer with recurrence or progression
following therapy with letrozole or anastrozole.
In the landmark study called BOLERO-2 (Breast cancer trials of OraL
EveROlimus-2), a total of 724 patients were randomized to receive
either the combination of everolimus (10 mg daily) plus exemestane (25
mg daily) or placebo plus exemestane arm. This pivotal study
demonstrated a statistically significant clinical benefit of everolimus
plus exemestane over placebo plus exemestane by more than doubling
median progression-free survival (PFS) (median: 7.36 months versus 3.19 months).3
The most common adverse events (incidence ≥ 30%) were stomatitis,
infections, rash, fatigue, diarrhea and decreased appetite. The most
common grade 3-4 adverse events (incidence ≥ 3%) were stomatitis,
infections, fatigue, dyspnoea and pneumonitis.2,3,11
To help patients access AFINITOR*, Novartis Pharmaceuticals Canada Inc.
(Novartis Oncology) is offering a patient support program called
AfiniTRACTM. The AfiniTRACTM program pursues coverage options for patients and may provide financial
assistance, in some cases, for qualified patients. In addition, when
registering into the program, patients will receive a Patient Starter
Kit which includes a booklet on managing their disease and
understanding the possible side effects associated with treatment, as
well as sample products that can help with the management of treatment.
For more information about this program, patients are encouraged to
call the AfiniTRAC™ hotline at 1-888-6AFINITOR.
*VEGF receptor TKIs = vascular endothelial growth factor receptor
tyrosine kinase inhibitors
About Novartis Oncology
Novartis Oncology has advanced the treatment of patients with breast
cancer across the disease continuum. In addition to developing
medicines that are specifically aimed at breast cancer, Novartis is a
leader in seeking to improve outcomes for cancer patients, having
brought to market the first medical therapy for the treatment of
patients with bone complications associated with advanced malignancies,
PrAREDIA* (pamidronate disodium), more than 20 years ago.
Since then, Novartis Oncology has a proven track record of discovering
and developing therapies that aim to change the way patients live with
various types of cancer. The company's commitment to breast cancer
patients is demonstrated by PrFEMARA* (letrozole) and PrZOMETA* (zoledronic acid).
For more than 20 years, Novartis Oncology has helped pave the way for
significant advances in the treatment of patients with breast cancer.
The company's research priorities are determined by patient need and
disease understanding. Novartis Oncology's research strategy is to
identify the structure of a tumour and the molecular pathways of the
disease to develop targeted medicines that address the unmet medical
needs of patients.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.
*AFINITOR, AREDIA, FEMARA, and ZOMETA are registered trademarks.
1 Redmond C. Breast Cancer Hormone Therapy Options. Available at: http://suite101.com/article/breast-cancer-hormone-therapy-options-a197304 Accessed April 27, 2012.
2 Baselga J. Everolimus in Postmenopausal Hormone-Receptor-Positive
Advanced Breast Cancer. New England Journal of Medicine. February 9,
3 AFINITOR* Product Monograph.
4 Canadian Cancer Society. Breast cancer statistics at a glance.
Available at: http://www.cancer.ca/canada-wide/about%20cancer/cancer%20statistics/stats%20at%20a%20glance/breast%20cancer.aspx. Accessed June 4, 2012.
5 Bernard-Marty C. Facts and Controversies in Systemic Treatment of
Metastatic Breast Cancer. The Oncologist. 2004;9:617-632. Available at:
http://theoncologist.alphamedpress.org/content/9/6/617.full. Accessed June 4, 2012.
6 Eniua A, Palmierib F and Perez E. Weekly Administration of Docetaxel
and Paclitaxel in Metastatic or Advanced Breast Cancer. The Oncologist,
7 Giordano S. Update on Locally Advanced Breast Cancer. The Oncologist,
8 Osborne CK, Schiff R. Mechanisms of endocrine resistance in breast
cancer. Annu Rev Med. 2011;62:233-47.
9 National Cancer Institute. What You Need to Know About Advanced Breast
Cancer. Available at: http://www.cancer.gov/cancertopics/wyntk/breast/WYNTK_breast.pdf. Accessed on March 8, 2012.
10 Hortobagyi, GN. Everolimus for postmenopausal women with advanced
breast cancer: updated results of the BOLERO-2 phase III trial. SABCS
2011. November 8, 2011.
11 Piccart, Martine. Everolimus for Postmenopausal Women with Advanced
Breast Cancer: Updated Results of the BOLERO-2 Phase III Trial. Poster
#559. American Society of Clinical Oncology Annual Meeting.
SOURCE: Novartis Pharmaceuticals Canada Inc.
For further information:
External Communications, Novartis Pharmaceuticals Canada Inc.
(514) 631-6775 ext. 1033
Consultant, GCI Group (416) 486-7231