New drug approvals expand treatment options for Canadians facing cancer and early Alzheimer's disease
Health Canada has issued several significant approvals and recommendations for new therapies addressing cancer and Alzheimer’s disease.
These decisions include the authorization of Enhertu (trastuzumab deruxtecan) for certain breast cancer patients, a conditional approval for LEQEMBI (lecanemab) for early Alzheimer’s disease, and a reimbursement recommendation for ELAHERE (mirvetuximab soravtansine) for platinum-resistant ovarian cancer.
Health Canada granted a Notice of Compliance (NOC) for Enhertu for adult patients with unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and are not suitable for further endocrine therapy.
The approval is based on results from the phase III DESTINY-Breast06 trial, which showed a reduction in the risk of disease progression or death compared to chemotherapy, as well as higher objective response rates and longer median progression-free survival in the Enhertu group.
Health Canada also issued a Notice of Compliance with Conditions (NOC/c) for LEQEMBI (lecanemab), a monoclonal antibody for adult patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease who are apolipoprotein E ε4 non-carriers or heterozygotes and have confirmed amyloid pathology.
LEQEMBI is the first treatment for early Alzheimer’s disease that targets an underlying cause of the condition and is approved in over 50 countries and regions.
The approval is based on the Phase 3 Clarity AD study, in which LEQEMBI met its primary and secondary endpoints.
Canada’s Drug Agency (CDA-AMC) recommended ELAHERE (mirvetuximab soravtansine) for reimbursement with conditions for adult patients with folate receptor-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.
The recommendation was made as part of the Target Zero initiative, which aims to accelerate access to promising new treatments.
ELAHERE is an antibody-drug conjugate and the first new treatment option in Canada for hard-to-treat platinum-resistant ovarian cancers in over a decade.
