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Berahyaluronidase Alfa and Pembrolizumab · Keytruda, Keytruda Qlex

Monoclonal antibody · Antagonist of PD-1 (PDCD1) and hyaluronan · developed by Merck Sharp Dohme

Approved FDA, Sep 2025

MRK Developer

1 Registered trials

What is Berahyaluronidase Alfa and Pembrolizumab?

Keytruda Qlex is a fixed-dose combination of pembrolizumab, a PD-1-blocking monoclonal antibody, and berahyaluronidase alfa, a hyaluronidase variant that temporarily breaks down hyaluronan in subcutaneous tissue to enhance drug absorption. Pembrolizumab blocks PD-1 on T cells, releasing immune checkpoint inhibition and activating anti-tumor immune responses.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Keytruda, Keytruda Qlex
Drug type: Monoclonal antibody
Targets: PD-1 (PDCD1), hyaluronan
Mechanism: Antagonist of PD-1 (PDCD1) and hyaluronan
Pathways: T-cell activation, immune checkpoint inhibition
Therapy area: Oncology
Developer: Merck Sharp Dohme (MRK)
FDA status: Approved as Keytruda, Keytruda Qlex (September 19, 2025), BLA761467 · FDA label

✅ FDA-approved uses

Unresectable or metastatic melanoma (Keytruda Qlex)
Adjuvant treatment of Stage IIB, IIC, or III melanoma following complete resection (Keytruda Qlex)
Metastatic nonsquamous NSCLC (first-line, with pemetrexed and platinum chemotherapy) (Keytruda Qlex)
Metastatic squamous NSCLC (first-line, with carboplatin and paclitaxel or paclitaxel protein-bound) (Keytruda Qlex)
NSCLC with PD-L1 TPS ≥1% (first-line, single agent) (Keytruda Qlex)
Metastatic NSCLC with PD-L1 TPS ≥1% (disease progression after platinum-containing chemotherapy) (Keytruda Qlex)
Resectable NSCLC (neoadjuvant and adjuvant treatment) (Keytruda Qlex)
Adjuvant treatment of Stage IB, II, or IIIA NSCLC following resection and platinum-based chemotherapy (Keytruda Qlex)

From the indications section of the FDA label (version of Jul 31, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT07190248	Phase 3	Non-small Cell Lung Cancer	Recruiting	MRK

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Non-small Cell Lung Cancer

Other drugs acting on PDCD1

Nivolumab FDA approved Pembrolizumab FDA approved Toripalimab FDA approved Atigotatug/Nivolumab Phase 1 Balstilimab Phase 2/3 BPT567 Phase 1 Budigalimab Phase 2/3 Cadonilimab Early Phase 1 CDX-585 Phase 1 CTX-8371 Phase 1 Geptanolimab Phase 1/2 Ivonescimab Phase 3

More from Merck Sharp Dohme

BCG Live FDA approved Belzutifan FDA approved Berahyaluronidase Alfa FDA approved Enlicitide FDA approved Ensifentrine FDA approved Letermovir FDA approved Pembrolizumab FDA approved Probenecid FDA approved Alimatravir Phase 2 Bomedemstat Phase 2/3 Calderasib Phase 3 Favezelimab Phase 1/2

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the MRK page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z