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New Indication Alert: Health Canada Approves Merck/MSD’s Keytruda® (Pembrolizumab) for Resectable NSCLC

Feb 11, 2025

On 11 February 2025, Merck (known as MSD outside the US and Canada) announced that Health Canada has approved Keytruda® (pembrolizumab) for the treatment of adults with resectable Stage II, IIIA, or IIIB non-small cell lung carcinoma (NSCLC), in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.

Keytruda® has been approved for the same indication in Europe (March 2024) and the US (October 2023), based on data from the Phase 3 KEYNOTE-671 trial.

Keytruda® was first approved in Canada in 2015 and has numerous cancer indications (alone or in combination therapy) including melanoma, bladder cancer, gastric cancer, and adenocarcinoma.