FDA Approves Subcutaneous Formulation of Pembrolizumab (Keytruda Qlex) for Solid Tumors

On September 19, 2025, the FDA approved pembrolizumab and berahyaluronidase alfapmph (Keytruda Qlex) for subcutaneous injection in adult and pediatric patients (12 years and older) with solid tumor indications previously approved for the intravenous formulation of pembrolizumab (Keytruda).¹

Efficacy and Safety

The approval was supported by results from Study MK-3475A-D77 (NCT05722015), a randomized, multicenter trial of 377 patients with treatment-naive metastatic non–small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 aberrations. Patients received either Keytruda Qlex (subcutaneous) or Pembrolizumab (intravenous) every 6 weeks with platinum doublet chemotherapy.

The trial demonstrated pharmacokinetic comparability between the two formulations, meeting predefined thresholds for cycle 1 AUC and cycle 3 Ctrough. The overall response rate was 45% (subcutaneous) vs 42% (intravenous). No notable differences were observed between the progression-free survival and overall survival.

Safety

The prescribing information includes warnings for immune-mediated adverse reactions, hypersensitivity, administration-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity. Keytruda Qlex offers a new subcutaneous option for patients, providing similar efficacy and safety to the intravenous formulation.

Reference

1. US Food and Drug Administration. FDA approves pembrolizumab and berahyaluronidase alfa-pmph subcutaneous injection. Published October 2023. Accessed October 6, 2023. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection