Health Canada has granted approval for KEYTRUDA SC™ (pembrolizumab injection), introducing a subcutaneous formulation of the well-established immunotherapy developed by Merck & Co., Inc. (MSD outside the U.S. and Canada).
This decision authorizes the marketing of the new injection format across multiple previously approved cancer indications, expanding administration options for eligible patients.
What Changes with the SC Formulation?
Until now, pembrolizumab has been administered intravenously. The newly approved subcutaneous (SC) version allows delivery under the skin, offering a more streamlined administration process while maintaining clinical consistency with the IV formulation.
Evidence Behind the Approval
The authorization was supported by data from Study MK-3475A-D77, a randomized, open-label, multicenter trial in patients with treatment-naïve metastatic non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 genomic alterations.
Key findings:
- Pharmacokinetic noninferiority of SC vs. IV administration
- Comparable objective response rate (ORR)
- Similar progression-free survival (PFS) outcomes
- Safety profile consistent with IV KEYTRUDA®, with mild injection-site reactions observed in a small percentage of patients
Patients in the study received:
- 790 mg pembrolizumab subcutaneously every six weeks
or - 400 mg pembrolizumab intravenously every six weeks
Both regimens were combined with platinum doublet chemotherapy.
Clinical Significance
Pembrolizumab is an anti–PD-1 monoclonal antibody that enhances the immune system’s ability to recognize and attack tumor cells. The SC formulation also includes berahyaluronidase alfa, which facilitates drug dispersion and absorption in subcutaneous tissue.
The availability of a subcutaneous option may support more flexible treatment workflows in oncology practices and potentially improve patient experience.
Commercial rollout timing in Canada will depend on reimbursement decisions at the provincial and territorial levels.
