FDA

FDA OKs SC formulation of Keytruda

September 24, 2025

Brand name: Keytruda Qlex

Generic name: pembrolizumab and berahyaluronidase alfa-pmph

Manufacturer: Merck

Approval date: September 19, 2025

FDA has approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for SC injection for adult and pediatric (≥12 years) solid tumor indications approved for the IV formulation of pembrolizumab (Keytruda).

Efficacy

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), with no EGFR, ALK, or ROS1 genomic tumor aberrations. A total of 377 patients were randomized (2:1) to receive either Keytruda Qlex administered SC every six weeks with platinum doublet chemotherapy or pembrolizumab administered IV every six weeks with platinum doublet chemotherapy.

The primary objective was to assess the exposure of SC Keytruda Qlex vs. IV pembrolizumab, with dual primary pharmacokinetic (PK) endpoints of cycle 1 AUC_{0-6 weeks} and cycle 3 (i.e., steady state) C_trough. 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% confidence interval [CI] for cycle 1 AUC_0-6weeks and 94% CI for cycle 3 C_trough) 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 SC Keytruda Qlex arm and 42% (95% CI, 33, 51) in the IV pembrolizumab arm. There were no notable differences in PFS or OS observed in patients who received Keytruda Qlex compared with patients who received IV pembrolizumab.

Safety

The most common adverse reactions reported with Keytruda Qlex in combination with chemotherapy were nausea, fatigue, and musculoskeletal pain. 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 dose

The recommended dosage of Keytruda Qlex is either 395 mg of pembrolizumab and 4,800 units of berahyaluronidase alfa-pmph every three weeks or 790 mg/9,600 units every six weeks until disease progression or unacceptable toxicity, or as indicated in the prescribing information.

Keytruda Qlex must be administered by a health care provider.

Sources:

FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection [News release]. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection

Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761467s000lblOrig2.pdf Revised September 2025. Accessed September 23, 2025.