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Pembrolizumab

Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.

IDDRUG-PEMBROLIZUMAB
TypeDrug
Aliases
KeytrudaПембролізумаб
Statusreviewed 2026-04-26 | pending_clinical_signoff
DiseasesDIS-BREAST DIS-CERVICAL DIS-CHL DIS-CHOLANGIOCARCINOMA DIS-CRC DIS-ENDOMETRIAL DIS-ESOPHAGEAL DIS-HNSCC DIS-MELANOMA DIS-NSCLC DIS-RCC DIS-UROTHELIAL
SourcesSRC-ESMO-BREAST-METASTATIC-2024 SRC-NCCN-BREAST-2025

Drug Facts

ClassAnti-PD-1 humanized IgG4-kappa monoclonal antibody (immune checkpoint inhibitor)
MechanismHumanized IgG4 monoclonal antibody binding the programmed cell death protein 1 (PD-1) receptor on activated T cells, B cells, and NK cells. Blocks the PD-1/PD-L1 and PD-1/PD-L2 interactions, releasing the tumor-induced inhibition of cytotoxic T-cell activity and restoring anti-tumor immunity. IgG4 backbone minimizes ADCC. Activity correlates with tumor PD-L1 expression (CPS or TPS), tumor mutational burden (TMB-H ≥10 mut/Mb), microsatellite instability (MSI-H / dMMR), and inflamed tumor microenvironment phenotypes. Approved across many solid tumors and classical Hodgkin / PMBCL lymphoma.
Typical dosingStandard adult: 200 mg IV q3 weeks OR 400 mg IV q6 weeks (over 30 min). Pediatric: 2 mg/kg (up to 200 mg) IV q3w. Treatment continued until disease progression, unacceptable toxicity, or 24 months in most solid-tumor indications (35 cycles q3w). Adjuvant melanoma: 1 year (KEYNOTE-054). Neoadjuvant + adjuvant TNBC (KEYNOTE-522): 200 mg q3w × 8 cycles with chemo, then 9 cycles adjuvant. Neoadjuvant + adjuvant NSCLC (KEYNOTE-671): 200 mg q3w × 4 cycles with platinum-doublet, then 13 cycles adjuvant. Combination doses unchanged when paired with chemo, lenvatinib, axitinib, or trastuzumab.
Ukraine registeredTrue
NSZU reimbursedTrue
Ukraine last verified2026-04-27

Warnings

Notes

Cross-disease entity. ICI-class management protocols apply uniformly: baseline TFTs, cortisol, glucose, LFTs, renal panel, troponin if combo with CTLA-4 ICI; serial labs every cycle. Grade 2 irAE — hold, start prednisone 0.5-1 mg/kg/d; Grade 3-4 — discontinue, prednisone 1-2 mg/kg/d, escalate to infliximab/MMF/IVIG/tocilizumab if refractory. Permanent discontinuation for any Grade 3-4 endocrine event NOT required if hormone replacement controls (most can resume). Endpoint predictors: PD-L1 CPS / TPS by 22C3 IHC, MSI/dMMR, TMB. PD-L1 cutoff varies by indication (TPS ≥1% NSCLC adjuvant, TPS ≥50% NSCLC 1L mono, CPS ≥1 gastric, CPS ≥10 cervical / TNBC met).

Used By

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