Health Canada Authorizes Verzenio as the First and Only CDK4/6 Inhibitor for Patients with Breast Cancer

Lilly Canada announced that Health Canada has authorized Verzenio® (abemaciclib) (tablets), in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of disease recurrence based on clinicopathological features and a Ki-67 score ≥20%. Ki-67 is a marker of cellular proliferation. Verzenio is the first and only CDK4/6 inhibitor approved for this patient population. Verzenio was previously approved by Health Canada in August 2019 for metastatic breast cancer.

"This is an important approval for Canadian patients who are diagnosed with high-risk early-stage breast cancer," says Dr. Christine Brezden-Masley, Medical Director, Cancer Program at Sinai Health in Toronto. "We know that effectively treating cancer early provides the best opportunity for a long-term prognosis, and with compelling data showing a reduction in cancer recurrence after two years, this is a great new option for these patients."

"A breast cancer diagnosis is devastating. And when diagnosed in a young woman, it can be more aggressive and with a greater risk of recurrence. But regardless of the age or stage, what all breast cancer patients want is the path that will lead them to the best possible outcome," says MJ DeCoteau, Executive Director of Rethink Breast Cancer. "We're hopeful this new approval in the early setting will have an equally positive impact on patient outcomes as CDK4/6 inhibitors have had in the metastatic setting – which has truly been a game changer."

"Expanding options for Canadian patients with HR+ HER2- early breast cancer is incredibly important, especially when we know that treating aggressively early, can lead to positive patient outcomes later on," says Cathy Ammendolea, Chair of the Board of Directors for the Canadian Breast Cancer Network. "This is great news for the breast cancer community in Canada."

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