Posts tagged Health Canada
Health Canada Authorizes Verzenio® (abemaciclib) as the First and Only CDK4/6 Inhibitor for patients with HR+ HER2- High Risk Early Breast Cancer

Adding Verzenio to endocrine therapy demonstrated a significant and clinically meaningful reduction in the risk of recurrence in patients with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-), node-positive, high risk early breast cancer and a Ki-67 score of ≥20%. Verzenio was first authorized in Canada in 2019 for the treatment of estrogen and/or progesterone HR+ HER2-, metastatic breast cancer (mBC)

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Health Canada approves first-ever gene replacement therapy, Luxturna®

Novartis Pharmaceuticals Canada Inc. is pleased to announce that Health Canada has approved Luxturna® (voretigene neparvovec), a one-time gene therapy for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. The presence of biallelic RPE65 mutations should be confirmed by an accredited laboratory using validated assay methods.

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