Kisqali® Receives Positive Draft Recommendation From Canada's Drug Agency For All Eligible Early Breast Cancer Patients at High Risk of Recurrence

• The draft recommendation for Kisqali^® (ribociclib tablets) from Canada's Drug Agency (CDA-AMC) supports public reimbursement for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II-III early breast cancer (eBC) in patients at high risk of recurrence.¹
• Breast cancer is the most common cancer diagnosed among Canadian women.² While many are diagnosed and treated early, some patients remain at high risk of their cancer coming back.³

MONTREAL, Feb. 6, 2026 /CNW/ - Novartis Canada applauds Canada's Drug Agency (CDA-AMC) for its positive draft recommendation to reimburse Kisqali^® (ribociclib tablets) for all eligible early breast cancer (eBC) patients at high risk of recurrence.¹

"This draft recommendation is a significant and welcome step forward for the Canadian breast cancer community, moving us closer to ensuring that all eligible patients have timely and equitable access to evidence-based therapies that can help prevent recurrence," said Kimberly Carson, CEO, Breast Cancer Canada. "By acknowledging the real risk and ongoing fear of recurrence faced by patients, this decision underscores the urgency of improving long-term outcomes for those with lived experience of breast cancer."

Approved by Health Canada in June 2025, Kisqali^® (ribociclib tablets), in combination with an aromatase inhibitor, is indicated for the adjuvant treatment of adult patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) stage II–III early breast cancer (eBC) at high risk of recurrence. Kisqali^® is a treatment given after surgical removal of cancer to help prevent it from returning.⁴

In clinical trials, Kisqali^® demonstrated a significant 28% reduction in the risk of recurrence across a broad population of high risk eBC patients.⁵ Within this broad population, a 40% reduction in the risk of recurrence was achieved for patients who presented with high risk features despite the absence of cancer in their lymph nodes at 5 years follow up.⁵

"CDA-AMC's draft recommendation represents a meaningful advancement in the treatment landscape for patients with early-stage hormone receptor positive/HER2-negative breast cancer," said Dr. Katarzyna Jerzak, Medical Oncologist at Sunnybrook's Odette Cancer Center and Associate Professor of Medicine at University of Toronto. "Broadening treatment options provides physicians with the necessary flexibility to personalize care and proactively address the risk of recurrence."

In granting its positive draft recommendation, CDA-AMC acknowledged the significant unmet need for additional treatment options in early breast cancer and highlighted the statistical benefit demonstrated with Kisqali^® in reducing the risk of recurrence across all eligible patients.¹

"This draft recommendation reflects a shared commitment to ensuring that the benefits of therapeutic innovation reach every eligible patient in Canada," said Dimitri Gitas, Country President of Novartis Canada. "By advancing the treatment landscape in early breast cancer, we are working toward a future where more people have the opportunity to manage their health and look forward with greater confidence."

Once the final recommendation is issued by CDA-AMC, the file will proceed to the pan-Canadian Pharmaceutical Alliance (pCPA) for pricing and reimbursement negotiations. While this positive draft recommendation represents an important first step, timely action from provincial jurisdictions will be essential to ensure that all eligible patients can access Kisqali^® without delay.

About early breast cancer (eBC)
Breast cancer is the most commonly diagnosed cancer among Canadian women, with approximately 70% of cases diagnosed in the early stages of the disease.^6,7,8 However, despite existing treatment options, people with stage II and III HR+/HER2- eBC remain at significant high risk of recurrence.^8,9

The risk of recurrence is influenced by factors such as lymph node involvement, tumor size, tumor grading, age at diagnosis, and biomarkers. While patients without lymph node involvement were previously considered to have lower risk, nearly 25% of those with HR+/HER2- eBC may experience recurrence within 20 years.^10,11 Approximately 90–95% of metastatic breast cancer cases originate from earlier diagnoses of early breast cancer, which were initially treated with combinations of hormonal therapy and chemotherapy.¹² If the cancer does recur, 80% of those recurrent cases have already spread, making them incurable.¹³

 About Kisqali^® (ribociclib tablets)

Kisqali was previously approved by Health Canada on March 2^nd, 2018, for the treatment of patients with HR+/HER2- advanced or metastatic breast cancer.¹⁴

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 with enhanced precision aides the control of cancer cell replication.¹⁵

In eBC, Kisqali® is the only CDK4/6 inhibitor recommended for all node-positive disease as well as patients with high risk disease characteristics despite no nodal involvement.^{16, 17}

The National Comprehensive Cancer Network (NCCN) guidelines recommend ribociclib (Kisqali^®) as a Category 1 preferred CDK4/6 inhibitor for breast cancer patients.¹⁸ Kisqali® in combination with an aromatase inhibitor (AI), has the highest score (A) on the ESMO-Magnitude of Clinical Benefit Scale for the adjuvant treatment of adults with stage II and III HR+/HER2- eBC, at high risk of recurrence.¹⁸

The most common Adverse Drug Reactions across the NATALEE study (>20% and exceeding the frequency for AI alone) were neutropenia (62.5% vs. 4.6%), infections (36.3% vs. 26.3%), nausea (23.3% vs.7.8%, headache (23.0% vs. 17.1%), fatigue (22.3% vs. 13.2%), leukopenia (22.3% vs. 3.6%), and abnormal liver function tests (22.3% vs. 7.6%).¹⁵

Please see the Product Monograph for Kisqali^®, available at https://www.novartis.com/ca-en/kisqalimonograph.

About Novartis

Novartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious diseases. Our medicines reach more than 250 million people worldwide.

In Canada, Novartis Pharmaceuticals Canada Inc. employs approximately 500 people to serve the evolving needs of patients and the healthcare system and invests over $30 million in R&D yearly in the country. For more information visit www.novartis.ca.

Kisqali^® is a registered trademark.

References

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¹ ribociclib | CDA-AMC

² Statistics Canada. (2024). Canadian Cancer Registry, 2022. The Daily. Ottawa, ON: Government of Canada

³ Pan H, Gray R, Braybrooke J, et al. 20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years (incl. supplementary appendix). N Engl J Med. 2017;377(19):1836-1846. doi:10.1056/NEJMoa1701830 

⁴ Novartis Canada. Health Canada approves Novartis' KISQALI® for HR+/HER2- early breast cancer patients at high risk of recurrence. Available at: Health Canada approves Novartis' KISQALI^® for HR+/HER2- early breast cancer patients at high risk of recurrence | Novartis Canada. Accessed February 2026

⁵ Crown, D. et al., Adjuvant ribociclib plus nonsteroidal aromatase inhibitor therapy in patients with HR-positive/HER2-negative early breast cancer: 5-year follow-up of NATALEE efficacy outcomes and updated overall survival, ESMO Open, 2025, 105858.

⁶ American Cancer Society. Breast Cancer Facts & Figures 2019-2020. 2019. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/breast-cancer-facts-and-figures-2019-2020.pdf. Accessed February 2026.

⁷ Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014;106(5):dju055. doi:10.1093/jnci/dju055.

⁸ Breast Cancer Now. Breast cancer recurrence. May 2019. Available at: https://breastcancernow.org/about-breast-cancer/diagnosis/breast-cancer-recurrence/. Accessed February 2026.

⁹ Novartis. FDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancer. Available at: https://www.novartis.com/news/media-releases/fda-approves-novartis-kisqali-reduce-risk-recurrence-people-hrher2-early-breast-cancer. Accessed February 2026.

¹⁰ ,Pan H, Gray R, Braybrooke J, et al. 20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years (incl. supplementary appendix). N Engl J Med. 2017;377(19):1836-1846. doi:10.1056/NEJMoa1701830

¹¹ Bushnell GG, Deshmukh AP, den Hollander P, et al. Breast cancer dormancy: need for clinically relevant models to address current gaps in knowledge. NPJ Breast Cancer. 2021;7(1):66. Published 2021 May 28. doi:10.1038/s41523-021-00269-x

¹² MD Anderson Cancer Center. Breast cancer recurrence: Which types of breast cancer are most likely to come back? Available at: Breast cancer recurrence: Which types of breast cancer are most likely to come back? | MD Anderson Cancer Center. Accessed February 2026.

¹³ Geurts YM, Witteveen A, Bretveld R, et al. Patterns and predictors of first and subsequent recurrence in women with early breast cancer. Breast Cancer Res Treat. Oct 2017;165(3):709-720. doi:10.1007/s10549-017-4340-3.

¹⁴ Novartis Canada. 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. Available at: https://www.newswire.ca/news-releases/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-681481661.html. Accessed February 2026.

¹⁵ Novartis. (2025). KISQALI Product Monograph. Available at: https://www.novartis.com/usen/sites/novartis_us/files/kisqali.pdf. Accessed February 2026.

¹⁶ Novartis Canada. Health Canada approves Novartis' KISQALI® for HR+/HER2- early breast cancer patients at high risk of recurrence. Available at: Health Canada approves Novartis' KISQALI^® for HR+/HER2- early breast cancer patients at high risk of recurrence | Novartis Canada. Accessed February 2026.

¹⁷ NCCN Guidelines. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) - Breast Cancer. Available at: https://www.nccn.org. Accessed February 2026.

¹⁸ European Society of Medical Oncology (ESMO). ESMO MCBS scorecards; NATALEE. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards/scorecard-468-1. Accessed February 2026.

SOURCE Novartis Pharmaceuticals Canada Inc.

Media Contact Information: Adam Miller, Communications and Patient Advocacy Lead, [phone], [email protected]