Keytruda Qlex FDA Approval History
FDA Approved: Yes (First approved September 19, 2025)
Brand name: Keytruda Qlex
Generic name: pembrolizumab and berahyaluronidase alfa-pmph
Dosage form: Injection
Company: Merck
Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) is a programmed death receptor-1 (PD-1)-blocking antibody and endoglycosidase combination indicated for the treatment of multiple types of cancer.
- Keytruda Qlex is indicated for use in the treatment of:
- Melanoma
- Non-Small Cell Lung Cancer (NSCLC)
- Malignant Pleural Mesothelioma (MPM)
- Head and Neck Squamous Cell Cancer (HNSCC)
- Urothelial Cancer
- Microsatellite Instability-High or Mismatch Repair Deficient Cancer
- Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC)
- Gastric Cancer
- Esophageal Cancer
- Cervical Cancer
- Hepatocellular Carcinoma (HCC)
- Biliary Tract Cancer (BTC)
- Merkel Cell Carcinoma (MCC)
- Renal Cell Carcinoma (RCC)
- Endometrial Carcinoma
- Tumor Mutational Burden-High (TMB-H) Cancer
- Cutaneous Squamous Cell Carcinoma (cSCC)
- Triple-Negative Breast Cancer (TNBC)
Development timeline for Keytruda Qlex
| Date | Article |
|---|---|
| Sep 23, 2025 | Approval FDA Approves Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) Subcutaneous Injection Formulation of Keytruda for Use in Solid Tumors |
Further information
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