Pembrolizumab/berahyaluronidase alfa

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Pembrolizumab/berahyaluronidase alfa
Combination of
Pembrolizumab Programmed death receptor-1 (PD-1) blocking antibody
Berahyaluronidase alfa Variant of hyaluronidase
Clinical data
Trade names Keytruda Qlex
License data
Routes of
administration 		Subcutaneous
ATC code
  • None
Legal status
Legal status

Pembrolizumab/berahyaluronidase alfa, sold under the brand name Keytruda Qlex, is a fixed dose combination medication used for the treatment of many types of solid tumors. [1] It contains pembrolizumab, a programmed death receptor-1 (PD-1) blocking antibody; and berahyaluronidase alfa, a variant of hyaluronidase. [1] It is given by injection under the skin (subcutaneous). [1]

Contents

Pembrolizumab/berahyaluronidase alfa was approved for medical use in the Unites States in September 2025. [2] [3]

Medical uses

Pembrolizumab/berahyaluronidase alfa is indicated for the solid tumor indications approved for the intravenous formulation of pembrolizumab. [1] [2]

Side effects

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]

History

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]

Society and culture

Pembrolizumab/berahyaluronidase alfa was approved for medical use in the Unites States in September 2025. [2]

Names

Pembrolizumab and berahyaluronidase alfa are international nonproprietary names. [4] [5] [6]

Pembrolizumab/berahyaluronidase alfa is sold under the brand name Keytruda Qlex. [1] [2]

References

  1. 1 2 3 4 5 6 https://www.merck.com/product/usa/pi_circulars/k/keytruda_qlex/keytruda_qlex_pi.pdf
  2. 1 2 3 4 5 6 7 "FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection". U.S. Food and Drug Administration (FDA). 19 September 2025. Retrieved 21 September 2025.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  3. ↑ "FDA Approves Merck's Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) Injection for Subcutaneous Use in Adults Across Most Solid Tumor Indications for Keytruda (pembrolizumab)". Merck (Press release). 21 September 2025. Retrieved 21 September 2025.
  4. ↑ "Pembrolizumab". WHO/OMS. Retrieved 21 September 2025.
  5. ↑ World Health Organization (2023). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 90". WHO Drug Information. 37 (3). hdl: 10665/373341 .
  6. ↑ World Health Organization (2024). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 91". WHO Drug Information. 38 (1). hdl: 10665/378096 .


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