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# Merck’s Keytruda Qlex Approved by FDA
- URL: https://www.fdaweb.com/mercks-keytruda-qlex-approved-by-fda/
- Published: 2025-09-19T12:00:00.000Z
- Updated: 2026-09-14T15:22:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159903

FDA has approved Merck’s pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab.

Approval was based on data from the Study MK-3475A-D77 (NCT05722015), a randomized, multicenter, open-label, active-controlled trial conducted in patients with treatment-naïve metastatic non-small cell lung cancer, in whom there were no EGFR, ALK, or ROS1 genomic tumor aberrations, according to an [agency release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection?ref=fdaweb.com). Efficacy outcome measures were overall response rate, progression-free survival (PFS) and overall survival (OS). The confirmed ORR was 45% in the subcutaneous Keytruda Qlex arm and 42% in the intravenous pembrolizumab arm. “There were no notable differences in PFS or OS observed in patients who received Keytruda Qlex compared to patients who received intravenous pembrolizumab,” FDA says.

The prescribing information includes warnings and precautions for immune-mediated adverse reactions, hypersensitivity and administration-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity, it adds.