| Combination of | |
|---|---|
| Pembrolizumab | Programmed death receptor-1 (PD-1) blocking antibody |
| Berahyaluronidase alfa | Variant ofhyaluronidase |
| Clinical data | |
| Trade names | Keytruda Qlex |
| License data | |
| Routes of administration | Subcutaneous |
| ATC code |
|
| Legal status | |
| Legal status | |
| Identifiers | |
| KEGG | |
Pembrolizumab/berahyaluronidase alfa, sold under the brand nameKeytruda Qlex, is afixed dose combination medication used for the treatment of many types ofsolid tumors.[1] It containspembrolizumab, aprogrammed death receptor-1 (PD-1) blocking antibody; andberahyaluronidase alfa, a variant ofhyaluronidase.[1] It is given byinjection under the skin (subcutaneous).[1]
Pembrolizumab/berahyaluronidase alfa was approved for medical use in the United States in September 2025.[2][3]
Pembrolizumab/berahyaluronidase alfa isindicated for thesolid tumor indications approved for theintravenous formulation ofpembrolizumab.[1][2]
The US FDA 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.[2]
The efficacy was evaluated in study MK-3475A-D77 (NCT05722015), a randomized, multi-center, open-label, active-controlled trial conducted in participants with treatment-naïve metastatic non-small cell lung cancer, in whom there were no EGFR, ALK, or ROS1 genomic tumor aberrations.[2] A total of 377 participants were randomized (2:1) to receive either pembrolizumab/berahyaluronidase alfa administered subcutaneously every six weeks with platinum doublet chemotherapy or pembrolizumab administered intravenously every six weeks with platinum doublet chemotherapy.[2]
Pembrolizumab/berahyaluronidase alfa was approved for medical use in the United States in September 2025.[2]
Pembrolizumab and berahyaluronidase alfa areinternational nonproprietary names.[4][5][6]
Pembrolizumab/berahyaluronidase alfa is sold under the brand name Keytruda Qlex.[1][2]
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