Health Canada Approves (Pr)AFINITOR* in Advanced Breast Cancer for Women Battling This Disease

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
        years ago(1)
    --  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 
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 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 
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, (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: 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: 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.

Celeste Brown External Communications, Novartis Pharmaceuticals Canada Inc. 
(514) 631-6775 ext. 1033  Amanda Federchuk 
Consultant, GCI Group (416) 486-7231 
SOURCE: Novartis Pharmaceuticals Canada Inc. 
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