Keytruda Qlex™

Understanding Keytruda Qlex™
Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa‑pmph) is a prescription medicine used for adult and pediatric patients 12 years and older for solid tumor indications that are already approved for intravenous pembrolizumab (Keytruda), as specified in the FDA‑approved prescribing information. It is a subcutaneous co‑formulation of pembrolizumab, a programmed death receptor‑1 (PD‑1)–blocking antibody, and berahyaluronidase alfa‑pmph, an endoglycosidase, designed to enable subcutaneous delivery of pembrolizumab. By blocking the PD‑1 pathway, pembrolizumab helps the immune system detect and fight cancer cells, while berahyaluronidase alfa‑pmph allows pembrolizumab to be administered subcutaneously rather than intravenously.

How Keytruda Qlex™ Works:

• Immune checkpoint inhibition: Keytruda Qlex™ contains pembrolizumab, a programmed death receptor‑1 (PD‑1)–blocking antibody. By binding to the PD‑1 receptor on T cells, pembrolizumab blocks its interaction with PD‑L1 and PD‑L2, thereby releasing PD‑1–mediated inhibition of the immune response. This enhances the body’s ability to recognize and attack tumor cells.
• Subcutaneous absorption and systemic activity: After subcutaneous administration, the co‑formulated component berahyaluronidase alfa‑pmph, an endoglycosidase, increases the dispersion and absorption of pembrolizumab, enabling effective systemic exposure comparable to intravenous pembrolizumab. Once absorbed, pembrolizumab exerts its immune‑mediated antitumor activity across the FDA‑approved indications for Keytruda Qlex.

FDA Approval:

2025 – Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa‑pmph) received its initial U.S. approval on September 19, 2025, for subcutaneous administration in adult and pediatric patients (12 years and older) across solid tumor indications already approved for intravenous pembrolizumab (Keytruda).

For more information, please visit the Keytruda Qlex™ patient website. Speak with your healthcare provider to determine if Keytruda Qlex™ is the right treatment option for you.