Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Health Canada has approved KEYTRUDA SC™ (pembrolizumab injection), a new subcutaneous formulation of pembrolizumab, Merck's anti–PD-1 therapy.

The approval is based on results from pivotal trial 3475A-D77, which compared pembrolizumab administered subcutaneously with pembrolizumab administered intravenously, both in combination with chemotherapy, in patients with treatment-naïve metastatic squamous or non-squamous non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 genomic tumor aberrations.

Use of KEYTRUDA SC™ for its authorized indications is supported by evidence from adequate and well-controlled studies conducted with intravenous KEYTRUDA®, across tumour types, and additional pharmacokinetic, efficacy, and safety data from Study MK-3475A-D77.