berahyaluronidase alfa-pmph

Berahyaluronidase alfa-pmph is a recombinant variant of human hyaluronidase formulated specifically for combination use with pembrolizumab in the fixed-dose co-formulation KEYTRUDA QLEX. Its role is to degrade hyaluronan, a component of the extracellular matrix, thereby enhancing the dispersion and permeation of subcutaneously administered pembrolizumab. This enables effective delivery of pembrolizumab via subcutaneous injection as opposed to intravenous infusion. The combination (pembrolizumab and berahyaluronidase alfa-pmph) is approved for a broad range of solid tumor indications previously authorized for pembrolizumab’s intravenous formulation, including melanoma, non-small cell lung cancer (NSCLC), and other tumor types with biomarkers such as MSI-high, dMMR, or TMB-high. Berahyaluronidase alfa-pmph does not have independent antitumor activity but serves as an enabling agent to improve bioavailability and absorption of pembrolizumab administered subcutaneously[1][3][5][7][9][10].