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On September 19, 2025, the Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda, Merck). See the prescribing information for the specific indications.
Full prescribing information for Keytruda Qlex will be posted on Drugs@FDA.
Efficacy and Safety
Efficacy was evaluated in 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 (NSCLC), in whom there were no EGFR, ALK, or ROS1 genomic tumor aberrations. A total of 377 patients were randomized (2:1) to receive either Keytruda Qlex administered subcutaneously every six weeks with platinum doublet chemotherapy or pembrolizumab administered intravenously every six weeks with platinum doublet chemotherapy.
The primary objective was to assess the exposure of subcutaneous Keytruda Qlex compared to intravenous pembrolizumab, with dual primary pharmacokinetic (PK) endpoints of Cycle 1 AUC0-6 weeks and Cycle 3 (i.e., Steady State) Ctrough. Descriptive efficacy outcome measures were overall response rate (ORR) by blinded independent central review (BICR), progression-free survival (PFS) by BICR, and overall survival (OS). The trial met the predefined acceptance margin for the PK endpoints with the lower boundary (96% CI for Cycle 1 AUC0-6weeks and 94% CI for Cycle 3 Ctrough) of the geometric mean ratios above the pre-specified threshold of 0.8 for comparability. The confirmed ORR was 45% (95% CI: 39, 52) in the subcutaneous Keytruda Qlex arm and 42% (95% CI: 33, 51) 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.
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.
Recommended Dosage
The recommended dosage is either 395 mg of pembrolizumab and 4,800 units of berahyaluronidase alfa-pmph every three weeks or 790 mg of pembrolizumab and 9,600 units of berahyaluronidase alfa-pmph every six weeks until disease progression or unacceptable toxicity, or as indicated in the prescribing information.
Expedited Programs
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
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