US pharmaceutical company Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada, announced on Tuesday that it has received Health Canada approval for KEYTRUDA (pembrolizumab) as a treatment for adult patients with resectable Stage II, IIIA or IIIB (T3-4N2) non-small cell lung carcinoma (NSCLC).
The therapy was approved in combination with platinum-containing chemotherapy as a neoadjuvant treatment, followed by monotherapy as adjuvant treatment after surgery.
The approval is based on data from the Phase 3 KEYNOTE-671 trial, which demonstrated statistically significant improvements in event-free survival and overall survival compared to chemotherapy and placebo. This marks the first anti-PD-1 therapy approved in Canada for perioperative NSCLC treatment.
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