Health Canada approves an extended indication for KISQALI® (ribociclib) in combination treatment

    --  Breast cancer is the most common female cancer in Canada.(1)
    --  Advanced breast cancer is the leading cause of cancer death in women
        20-59 years old.(2,3  )
    --  While overall 5-year survival rates for female breast cancer are
        relatively high, at 87%, women with advanced breast cancer face a 22.0%
        survival rate over 5 years.(4 )

DORVAL, QC, April 16, 2020 /CNW Telbec/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that KISQALI(® )(ribociclib) is now indicated when used in combination for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer regardless of their menopause status and in combination with various approved hormonal treatment options.

Health Canada has approved an extended indication for KISQALI(®): in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy, as well as in combination with an aromatase inhibitor (and luteinizing hormone releasing hormone [LHRH] agonist) for the treatment of pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer as initial endocrine-based therapy.(5 )The approval is based on results from the pivotal MONALEESA-3 and MONALEESA-7 trials.

For women living with metastatic breast cancer, also known as Stage IV breast cancer, the cancer has spread beyond the breast to other areas of the body, such as the lungs, liver, bones or brain.(6) It may happen before or after treatment, or it may develop from reoccurring breast cancer.(7) Although there have been advancements in early detection and treatment, there is still no cure for metastatic breast cancer.(8)

"The availability of a new treatment option for more women living with metastatic breast cancer is an important milestone," said Dr. Christine Brezden-Masley, Medical Oncologist, Mount Sinai Hospital and Medical Director, Cancer Program at Sinai Health System. "This option now brings the possibility of delayed disease progression and improved quality of life to a broader patient community."

"We've learned over the years of working with young women with metastatic breast cancer that they want to live as well as they can for as long as they can. Disease stability and quality of life are extremely important. HR-positive breast cancer is the most common type in younger women, and we are thrilled that this new option is now available and will help many more women," said MJ DeCoteau, Founder and Executive Director, Rethink Breast Cancer.

KISQALI(®) first received Health Canada approval for use with letrozole on March 2, 2018, for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer as first-line endocrine-based therapy based on findings from the pivotal MONALEESA-2 trial.

"At Novartis, we are at the forefront of driving scientific advancements and are proud to contribute to research in metastatic breast cancer," said Daniel Hébert, Country Medical Head Oncology, Novartis Pharmaceuticals Canada Inc. "The newest indication expansion for pre-, peri-, and postmenopausal women is testament to our long-standing commitment to bringing innovative therapies that can improve the quality of life to those impacted by breast cancer."

About KISQALI(®) (ribociclib)
KISQALI(®) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. KISQALI(®) was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

About Novartis in Advanced Breast Cancer
Novartis tackles breast cancer with advanced science, collaboration and a passion for transforming patient care. We've taken a bold approach to our research by including patient populations often neglected in clinical trials, identifying new pathways or mutations that may play a role in disease progression and developing therapies that not only maintain, but also improve, quality of life for patients. Our priority over the past 30 years and today is to deliver treatments proven to improve and extend lives for those diagnosed with advanced breast cancer.

About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2018, the company invested $52 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 1,000 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca.

KISQALI is a registered trademark.

References

     1   World Health Organization. Cancer Population Fact Sheet - Canada. Available at: http://gco.iarc.fr/today/data/factsheets/populations/124-
           canada-fact-sheets.pdf. Accessed on March 5, 2020.



     2 
     Benz CC. Impact of aging on the biology of breast cancer. Crit Rev Oncol Hematol. 2008;66:65-74.



     3   World Health Organization. Top cancer per country, estimated age-standardized mortality rates (world) in 2018, females, all ages. 2018. Available
           at: http://gco.iarc.fr/today/home. Accessed on March 5, 2020.



     4   Canadian Cancer Society. Canadian Cancer Statistics, a 2018 special report on cancer incidence by stage. Available at: www.cancer.ca/Canadian-
           Cancer-Statistics-2018-EN. Accessed on March 5, 2020.



     5 
     KISQALI(R), Product Monograph, February 6, 2020. Available at: www.novartis.ca/kisqalimonograph. Accessed on March 5, 2020.



     6   Canadian Cancer Society. What is Metastatic Cancer? Available at: http://www.cancer.ca/en/cancer-information/cancer-type/metastatic-cancer/
           metastatic-cancer/?region=on. Accessed on March 5, 2020.



     7   Canadian Breast Cancer Network. What is Metastatic Breast Cancer? Available at: https://www.cbcn.ca/en/what_is_mbc. Accessed on March 5, 2020.



     8   Canadian Breast Cancer Network and Rethink Breast Cancer. Living with Metastatic Breast Cancer in Canada. Available at: https://www.cbcn.ca/web/
           default/files/public/Reports/Metastatic%20Breast%20Cancer%20In%20Canada%20Report%20June%202013%20-%20English.pdf. Accessed on March 5, 2020.

SOURCE Novartis Pharmaceuticals Canada Inc.