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Health Canada Approves KEYTRUDA SC™, a subcutaneous formulation of pembrolizumab across multiple cancer indications
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.
About this update from Merck & Company, Inc.
[{"type":"text","content":"KIRKLAND, QC, Feb. 17, 2026 /PRNewswire/ -- 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.","length":289,"tagName":"p"},{"type":"image","alt":"Merck Logo (PRNewsfoto/Merck)","displaySize":"","headline":null,"caption":"Merck Logo (PRNewsfoto/Merck)","className":"","disableSlideshowImg":false,"size":{"original":{"width":148,"height":44,"url":"https://media.zenfs.com/en/cnwgroup.com/a31c818593c897369fcfa7d3a78ada87"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/WPGiatRLHK00PDoDVoPplg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIxMDtoPTYyO2NmPXdlYnA-/https://media.zenfs.com/en/cnwgroup.com/a31c818593c897369fcfa7d3a78ada87","width":148,"height":44}},"href":"https://mma.prnewswire.com/media/2814415/Merck_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"This Health Canada approval marks an important milestone for Merck in Canada. "We remain committed to bringing meaningful solutions to Canadian patients," said David D. Jones, Managing Director, Merck Canada. "By providing KEYTRUDA SC™, we aim to offer the flexibility of an additional administration option for eligible patients and help healthcare providers to deliver care in the way that best meets patient needs."","length":438,"tagName":"p"},{"type":"text","content":"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.","length":362,"tagName":"p"},{"type":"text","content":"The primary endpoints of the trial demonstrated that the subcutaneous (SC) formulation produced noninferior levels of pembrolizumab in the blood compared to the intravenous (IV) formulation based on pharmacokinetic exposure measures (Ctrough: minimum concentration in the blood; AUC0-6weeks: area under the curve from time zero to dosing interval).","length":353,"tagName":"p"},{"type":"text","content":"This decision authorizes the marketing of the subcutaneous formulation of pe...