Health Canada has granted approval for Novartis’ Kisqali (ribociclib tablets) in combination with an aromatase inhibitor for reducing recurrence in early breast cancer.
This treatment is intended for adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer at high risk of recurrence.
Health Canada’s authorisation follows the findings from the global Phase III NATALEE trial, which demonstrated that combining ribociclib with an aromatase inhibitor significantly reduced the likelihood of disease recurrence over the use of an aromatase inhibitor alone.
The NATALEE trial, involving a diverse patient population with stage II and III HR+/HER2- early breast cancer, showed that the addition of ribociclib to an aromatase inhibitor resulted in a 25.1% relative reduction in the risk of invasive disease-free survival events compared to those receiving only an aromatase inhibitor.
The open-label, randomised study evaluated Kisqali combined with an aromatase inhibitor against aromatase inhibitors alone across 5,101 adult patients from 20 countries. It assessed invasive disease-free survival as its primary endpoint according to Standardized Definitions for Efficacy End Points criteria.
The safety profile of ribociclib was well-tolerated among various subgroups in this pivotal trial.
Novartis Canada country president Mark Vineis said: “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,18 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.
“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.”
Previously, in March 2018, Kisqali had received approval from Health Canada for patients with advanced or metastatic HR+/HER2- breast cancer.
Kisqali, a selective cyclin-dependent kinase inhibitor, targets and inhibits cyclin-dependent kinase 4 and 6 proteins, which are involved in cancer cell growth and division. Inhibiting these proteins can slow cancer progression.
