Health Canada approves KISQALI™ for the treatment of HR-positive and HER2-negative metastatic breast cancer in postmenopausal women in combination with letrozole as an initial endocrine-based therapy

Arrival of new first-line therapy provides additional option for those living with this advanced form of breast cancer

DORVAL, QC, May 2, 2018 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that Health Canada has approved KISQALI^TM (ribociclib) in combination with an aromatase inhibitor (letrozole) for the treatment for hormone receptor HR-positive, human epidermal growth factor receptor 2 HER2-negative advanced or metastatic breast cancer as initial hormone-based therapy for postmenopausal women.¹ The approval is based on results from the pivotal MONALEESA-2 trial, which included eight Canadian trial sites, and 32 Canadian investigators. 

KISQALI^TM belongs to a family of medications called protein kinase inhibitors. These medications work by stopping cancer cells from dividing and growing.² KISQALI^TM is used with another anti-cancer medicine called letrozole, which is an aromatase inhibitor.² Aromatase inhibitors are hormone therapy drugs that stop the production or block the actions of aromatase, which in turn lowers the level of estrogen in the body.³ When given together with letrozole, KISQALI^TM may slow down the growth and spread of breast cancer cells.² 

"For women living with advanced breast cancer, the arrival of ribociclib as a new therapy option is promising news for patients," said Dr. Susan Dent, Medical Oncologist at The Ottawa Hospital Cancer Centre, Professor of Medicine, University of Ottawa, and Canadian investigator in the MONALEESA-2 trial. "Advanced breast cancer has no cure, however effective treatment can help delay disease progression."

For women living with advanced or 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.⁴ It may happen before or after treatment, or it may develop from reoccurring breast cancer.⁵ Although there have been advancements in early detection and treatment, there is still no cure for metastatic breast cancer.⁶

"We know that for many women living with metastatic breast cancer and their families, it can make a significant difference when a new treatment option is available," said Cathy Ammendolea, Chair of the Board of Directors, Canadian Breast Cancer Network. "This is good news and we look forward to seeing the impact that new treatments like this will have for many of those women living with this advanced form of breast cancer."

"The approval of KISQALI^TM is a testament to Novartis' commitment to bringing innovative therapies to market that will benefit those impacted by breast cancer," said Winselow Tucker, General Manager, Oncology Business Unit at Novartis Pharmaceuticals Canada Inc. "At Novartis, we're proud of our leadership in breast cancer over the last 25 years and the clinical trial program that led to the approval of KISQALI^TM."

For more than 25 years, Novartis has been at the forefront of driving scientific advancements for breast cancer patients and improving clinical practice in collaboration with the global community. With one of the most diverse breast cancer pipelines and the largest number of breast cancer compounds in development, Novartis leads the industry in discovery of new therapies and combinations, especially in HR+ breast cancer, the most common form of the disease.

About KISQALI^TM (ribociclib)
KISQALI^TM 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^TM was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals. 

Novartis Commitment to Oncology
At Novartis, our mission is to discover new ways to help improve and extend people's lives. We use science-based innovation to address some of society's most challenging healthcare issues. We discover and develop innovative treatments and find new ways to deliver them to as many people as possible. We strive to change the practice of medicine. We aspire to approach things differently - to make discoveries that take medicine in new directions. We look to tomorrow to inspire us today. Never satisfied with the status quo, we imagine what's next.

As one of the leading pharmaceutical companies in oncology, Novartis globally offers a portfolio of more than 20 approved therapies and approximately 30 compounds in development. We are passionate about what we do and the impact we have on patients and societies. We are Novartis, and we are reimagining medicine.

About Novartis Pharmaceuticals Canada  
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 2017, the company invested $51 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 750 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.    

About Novartis 
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 122,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com. 

KISQALI is a trademark.

References

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^1 KISQALI^TM, Product Monograph, March 19, 2018, p. 3. Available at: www.novartis.ca/kisqalimonograph. Accessed on March 13, 2018.
^2 KISQALI^TM, Patient Medication Information, March 19, 2018. Available at https://www.novartis.ca/en/our- products/pharmaceuticals#ui-id-1=10. Accessed on April 10, 2018.
^3 Canadian Cancer Society. Hormonal therapy for breast cancer. Available at: http://www.cancer.ca/en/cancer- information/cancer-type/breast/treatment/hormonal-therapy/?region=on. Accessed on April 10, 2018.
^4 Canadian Cancer Society. Metastatic Breast Cancer. Available at: http://cbcf.org/central/AboutBreastCancerMain/MetastaticBreastCancer/Pages/Metastatic-Breast- Cancer.aspx. Accessed on March 13, 2018.
^5 Canadian Breast Cancer Network. What is Metastatic Breast Cancer? Available at: https://www.cbcn.ca/en/what_is_mbc. Accessed on March 13, 2018.
^6 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%20 Report%20June%202013%20-%20English.pdf. Accessed on March 13, 2018.

SOURCE Novartis Pharmaceuticals Canada

Novartis Media Relations, Daphne Weatherby, Novartis Oncology Communications, [phone], E-mail: [email protected]