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Health Canada Approves KEYTRUDA (pembrolizumab) for the treatment of adult patients with high-risk early-stage...

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Benzinga
By Pr Newswire

Approval Based on Data from Phase 3 KEYNOTE-522 Trial

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KIRKLAND, QC, April 18, 2024 /CNW/ - Merck MRK, known as MSD outside the United States and Canada, today announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck'santi-PD-1 therapy, as a treatment for adult patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment after surgery.1 This approval is based on the results from the Phase 3 KEYNOTE-522 trial, which demonstrated a statistically significant improvement in event-free survival (EFS) and pathological complete response (pCR) rate among patients.1

I welcome this approval from Health Canada as an important milestone for patients with high-risk early-stage triple-negative breast cancer, said Dr. Jean-Franois Boileau, Professor of Surgery, McGill University and Surgical Oncologist, Montreal Jewish General Hospital. Having a new therapeutic option for the treatment of this challenging subset of cancer is a valuable advancement in this disease area.

In 2021, over 28,000 Canadians were estimated to be diagnosed with breast cancer,2one of the most common cancers among Canadian women,2 TNBC is an aggressive subtype of breast cancer that tends to grow and spread quickly.3 TNBC is also characterized by its high recurrence rate within the first five years after diagnosis.3 Many breast cancers have receptors for common therapeutic targets such as estrogen, progesterone, or HER2 whereas triple-negative breast cancer tests negative for all three,3 making this type of cancer difficult to treat as it has fewer treatment options.4

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