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Keytruda Qlex

Pembrolizumab And Berahyaluronidase Alfa-Pmph
PD-1 Inhibitor
Subcutaneous Injection

Keytruda Qlex is an FDA-approved subcutaneous formulation of Keytruda developed by Merck & Co. It contains the active immunotherapy molecule pembrolizumab, a PD-1 immune checkpoint inhibitor, combined with berahyaluronidase alfa, an enzyme that enables rapid subcutaneous delivery.
Unlike the traditional intravenous (IV) infusion of Keytruda administered over 30 minutes, Keytruda Qlex is given as a 1- or 2-minute subcutaneous injection every 3 or 6 weeks. Clinical studies in advanced non–small cell lung cancer (NSCLC) demonstrated comparable drug exposure and consistent safety between Keytruda Qlex and IV Keytruda, offering patients a faster administration option while maintaining therapeutic effectiveness.

Approval Date
19-Sep-25
Data Exclusivity Expiry
19-Sep-29
Market Exclusivity Expiry
19-Sep-37
Commercial snapshot

Market performance & projections

Revenue ($M)
40
CAGR (%)
2.8924
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
2439
2027
6045
2028
8089
2029
9182
2030
8690
2031
8627
2032
8011
Molecule profile

Details & specifications

Molecule
Pembrolizumab And Berahyaluronidase Alfa-Pmph
Innovator
MERCK SHARP & DOHME LLC
Dosage Form
Subcutaneous Injection
Strength
395 mg/4800 units (2.4 mL) and 790 mg/9600 units (4.8 mL)
Therapeutic Category
PD-1 Inhibitor
Usage
To treat adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab
Good to know

Frequently asked questions

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