Novartis Canada announced that Health Canada has granted a Notice of Compliance (NOC) for KISQALI® (ribociclib tablets) in combination with an aromatase inhibitor (AI) 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
Breast cancer is one of the most common cancers globally, with HR+/HER2- being the most prevalent subtype, accounting for approximately 70% of cases. Over 40% of HR+/HER2- breast cancer cases are diagnosed at stage II or III, with a high risk of recurrence for up to 20 years. If cancer recurs, it is often metastatic which in most cases is considered incurable. This progression significantly increases the burden on patients, caregivers, and healthcare systems, both financially and emotionally. On average, 15 Canadian women will die from breast cancer every day.
"Over our years supporting younger patients, we've seen far too many with HR+ breast cancer become metastatic even while on maintenance endocrine therapy," said MJ DeCoteau, Founder and Executive Director, Rethink Breast Cancer. "Breast cancer is often more aggressive in younger patients, and they have higher rates of recurrence despite early treatment. So, we were thrilled to see that the positive results for KISQALI for early breast cancer are the same for patients of all ages, regardless of stage and nodal status. Our community desperately wants more effective tools to help improve their chances against this challenging disease that's turned their life plans upside-down. This Health Canada approval is an exciting step forward."
The Health Canada approval is based on the global Phase III NATALEE trial, which included a broad patient population with HR+/HER2- stage II and III eBC. At the final analysis, this clinical trial demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence with ribociclib plus AI compared to AI alone. Among patients with stage II and stage III eBC, ribociclib added to AI demonstrated a 25.1% relative reduction in the risk of an invasive disease-free survival (iDFS) event compared with AI alone,1 with a well-tolerated safety profile seen across all subgroups in pivotal Phase III NATALEE trial.
"In the NATALEE trial, ribociclib demonstrated significant efficacy for a broad population of patients with early breast cancer," said Dr. Stephen Chia, Medical Oncologist, BC Cancer and Steering Committee member of the NATALEE trial. "This approval provides a new and expanded treatment option for these patients to help reduce their risk of cancer returning. Patients deserve access to the most effective treatment options, and their individual needs should always be at the centre of shared decision making. In every situation, it's critical to have an open, balanced risk-benefit discussion, in order to make the appropriate treatment decision that's best suited for the patient to reduce the risk of their cancer returning."
"While the risk of cancer returning peaks in the first five years after diagnosis, more than half of recurrences occur after this period, and the majority are metastatic and incurable," said Dr. Katarzyna Jerzak, Medical Oncologist, Sunnybrook Health Sciences Centre. "Ribociclib provides a new treatment option to help reduce the risk of recurrence and improve outcomes, particularly for patients at elevated risk. This approval expands our treatment arsenal with a targeted therapy that will have a meaningful impact on improving the care of patients diagnosed with early breast cancer in Canada."
"Novartis has been advancing innovative research and medical practice in breast cancer care for over 35 years, developing one of the most comprehensive pipelines in the field. Over 100,000 people with HR+/HER2- metastatic breast cancer have been treated with KISQALI globally, and now we're focused on expanding its use to those with stage II or III HR+/HER2- early breast cancer to reduce risk of recurrence," said Mark Vineis, Country President, Novartis Canada. "We are actively committed to working with our health system partners to ensure timely access to KISQALI and supporting Canadians and healthcare professionals to improve health outcomes."
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