Health Canada Approves (Pr)AFINITOR* in Advanced Breast Cancer for Women
Battling This Disease
-- Approval represents a development for Canadian patients with
hormone receptor-positive (HR+), HER2-negative advanced breast
cancer since aromatase inhibitors were introduced almost 15
-- 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 survival(2)
-- 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
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 years.(7)
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
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 survival(3).
"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 Network.
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 receptor-positive (HR+).
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
AfiniTRAC(TM). The AfiniTRAC(TM) 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
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, (Pr)AREDIA* (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 (Pr)FEMARA* (letrozole) and (Pr)ZOMETA* (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
*AFINITOR, AREDIA, FEMARA, and ZOMETA are registered trademarks.
(1) Redmond C. Breast Cancer Hormone Therapy Options. Available at:
Accessed April 27, 2012.
(2) Baselga J. Everolimus in Postmenopausal Hormone-Receptor-Positive Advanced
Breast Cancer. New England Journal of Medicine. February 9, 2012.
(3) AFINITOR* Product Monograph.
(4) Canadian Cancer Society. Breast cancer statistics at a glance. Available
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,
(6) Eniua A, Palmierib F and Perez E. Weekly Administration of Docetaxel and
Paclitaxel in Metastatic or Advanced Breast Cancer. The Oncologist, 2005.
(7) Giordano S. Update on Locally Advanced Breast Cancer. The Oncologist, 2003.
(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
(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.
Celeste Brown External Communications, Novartis Pharmaceuticals Canada Inc.
(514) 631-6775 ext. 1033 email@example.com Amanda Federchuk
Consultant, GCI Group (416) 486-7231 firstname.lastname@example.org
SOURCE: Novartis Pharmaceuticals Canada Inc.
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