The FDA approved a supplemental application for Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) on November 21, 2025. This approval, categorized under efficacy, was granted to sponsor MERCK SHARP DOHME.
Background
Pembrolizumab (marketed as Keytruda) is a well-established programmed death receptor-1 (PD-1) blocking antibody, widely used in oncology for various cancers. Keytruda Qlex is a co-formulation of pembrolizumab with berahyaluronidase alfa-pmph, an enzyme that facilitates the subcutaneous administration of large-molecule drugs. The original approval for Keytruda Qlex aimed to provide a subcutaneous option for patients receiving pembrolizumab. This supplemental approval specifically addresses the efficacy aspect of this co-formulation.
What this means
This supplemental approval for Keytruda Qlex, specifically for efficacy, signifies that the FDA has reviewed new data pertaining to the therapeutic effectiveness of the drug. Supplemental applications for efficacy can cover a range of updates, such as a new indication, an expanded patient population for an existing indication, or a modification to the dosing or administration regimen that impacts efficacy. For clinicians, this means there is updated information regarding how Keytruda Qlex performs in terms of its intended therapeutic effect. It is crucial for healthcare providers to consult the updated prescribing information and label for Keytruda Qlex to understand the precise nature of this efficacy update and its implications for patient care.
Source
The information regarding this supplemental approval was obtained from the FDA, specifically from the overview page for Biologics License Application (BLA) 761467 S-1, on accessdata.fda.gov. The approval date was November 21, 2025.