FDA Clears First Subcutaneous Keytruda: A New Era for Cancer Care

On September 19, 2025, the U.S. Food and Drug Administration (FDA) approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph, Merck) for subcutaneous injection. It is the first approval of Keytruda in a non-intravenous formulation, providing therapy to adult and pediatric patients (12 years and older) for all approved solid tumor indications of IV Keytruda.

Clinical Evidence

This was supported by the phase 3 MK-3475A-D77 trial of treatment-naive metastatic non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 mutations. 377 patients were randomized to receive subcutaneous Keytruda Qlex every six weeks alongside platinum-based chemotherapy or IV Keytruda alongside the same regimen.

The study demonstrated comparability of pharmacokinetics between the two regimens, meeting all criteria. ORR overall were 42% for IV Keytruda and 45% for Keytruda Qlex with no notable differences in PFS or OS.

Safety and Dosage

Keytruda Qlex safety profile was consistent with IV Keytruda. The most severe warnings are immune-mediated adverse effects, hypersensitivity, transplant-related complications, and embryo-fetal toxicity.

The approved dose is either 395 mg pembrolizumab + 4,800 units berahyaluronidase every three weeks, or 790 mg + 9,600 units every six weeks, until unacceptable toxicity or disease progression.

What It Means

With this approval, clinicians and patients have a more convenient subcutaneous alternative with the same efficacy and safety as IV Keytruda, which may decrease treatment burden and time in clinic.

Learn more: FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection | FDA