Keytruda Qlex (Subcutaneous Pembrolizumab + Berahyaluronidase) Receives FDA Approval
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Subcutaneous Immunotherapy: The New Standard?
FDA (Sep 19, 2025) approved Keytruda Qlex (pembrolizumab + berahyaluronidase alfa-pmph) for SC use across IV pembrolizumab’s approved solid-tumor indications (adults & ≥12y).
Keytruda Qlex (SC pembrolizumab)
- Trial: MK-3475A-D77 (NCT05722015), treatment-naïve metastatic NSCLC (EGFR/ALK/ROS1−).
- Primary: PK comparability (Cycle-1 AUC0–6w, Cycle-3 Ctrough).
- Sample: 377 pts (2:1; SC+chemo vs IV+chemo).
45%ORR (SC) vs 42% IV
≥0.8PK GMR lower bound met
1–2 minTypical SC admin time
Dosing: 395 mg + 4,800 U (Q3W) or 790 mg + 9,600 U (Q6W) until progression or unacceptable toxicity.
Key warnings: immune-mediated AEs, hypersensitivity/administration reactions, allogeneic HCT complications, embryo-fetal toxicity.
SC Ecosystem — Previously Approved Agents
Phesgo (pertuzumab + trastuzumab + hyaluronidase-zzxf)
HER2+ breast cancer; single SC combo dose. FDA: Jun 29, 2020.
Opdivo Qvantig (nivolumab + hyaluronidase-nvhy)
SC PD-1 across most IV indications. FDA: Dec 27, 2024. ~5 min admin.
Tecentriq Hybreza (atezolizumab + hyaluronidase-tqjs)
First SC PD-(L)1. FDA: Sep 12, 2024. ~7 min admin.
Herceptin Hylecta (trastuzumab + hyaluronidase-oysk)
SC trastuzumab in HER2+ breast cancer. Patient preference high (PrefHER).
| Drug (SC) | Class | Admin Time | Dose / Interval | Key Data |
|---|---|---|---|---|
| Keytruda Qlex | Anti-PD-1 + hyaluronidase | ~1–2 min | 395 mg Q3W or 790 mg Q6W | ORR 45% (SC) vs 42% (IV); PK comparable |
| Opdivo Qvantig | Anti-PD-1 + hyaluronidase | ~5 min | 600–1200 mg Q2–4W (regimen-dependent) | CM-67T: PK/efficacy align with IV |
| Tecentriq Hybreza | Anti-PD-L1 + hyaluronidase | ~7 min | 1,875 mg/15 mL Q3W | IMscin001: SC ≈ IV |
| Herceptin Hylecta | Anti-HER2 + hyaluronidase | Short | Fixed dose (EBC/MBC) | HannaH / SafeHER / PrefHER |
Sources
FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection. 19 Sep 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection
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