FDA Approves Use of Subcutaneous Pembrolizumab for NSCLC

The FDA approved the use of pembrolizumab (Keytruda; Merck) and berahyaluronidase alfa-pmph (Keytruda Qlex; Merck) for use in patients 12 years and older with solid tumor indications approved for the intravenous formulation of pembrolizumab.¹

The approval is based on the Study MK-3475A-D77 trial that evaluated the efficacy in patients with non–small cell lung cancer (NSCLC) who were treatment naive. The trial met the acceptance margin with an overall response rate (ORR) of 45% (95% CI, 39%-52%) in the subcutaneous pembrolizumab and berahyaluronidase arm compared with 42% (95% CI, 33%-51%) in the intravenous pembrolizumab arm.

Patients are recommended to take doses of either 395 mg of pembrolizumab with 4800 units of berahyaluronidase every 3 weeks or 790 mg of pembrolizumab and 9600 units of berahyaluronidase every 6 weeks.

Reference

1. FDA approves pembrolizaumab and berahyaluronidase alfa-pmph for subcutaneous injection. News release. FDA. September 19, 2025. Accessed September 19, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection