Cemiplimab
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-CEMIPLIMAB |
|---|---|
| Type | Drug |
| Aliases | LibtayoREGN2810cemiplimab-rwlcЦеміплімаб |
| Status | reviewed 2026-04-27 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-ESMO-NSCLC-METASTATIC-2024 SRC-NCCN-NSCLC-2025 |
Drug Facts
| Class | Anti-PD-1 monoclonal antibody (immune checkpoint inhibitor) |
|---|---|
| Mechanism | Fully human IgG4 monoclonal antibody (S228P-stabilized hinge to prevent Fab-arm exchange) that binds programmed cell death protein 1 (PD-1) on activated T cells, blocking engagement with its ligands PD-L1 and PD-L2 on tumor and antigen-presenting cells. The resulting release of T-cell inhibition restores cytotoxic anti-tumor immunity. Pharmacologic class is identical to pembrolizumab and nivolumab; binding kinetics differ modestly. Clinical contexts: advanced cutaneous SCC (Study 1540 / EMPOWER-CSCC: ORR ~47%, the first systemic FDA approval for cSCC), advanced basal cell carcinoma after Hedgehog-pathway inhibitor failure, NSCLC PD-L1 ≥50% 1L monotherapy (EMPOWER-Lung 1) or PD-L1 ≥1% 1L with platinum-doublet chemo (EMPOWER-Lung 3 / EMPOWER-Lung 1 expansion), recurrent / metastatic cervical cancer post-platinum (EMPOWER-Cervical 1). |
| Typical dosing | 350 mg IV over 30 minutes every 3 weeks (flat dose, not weight- based) until disease progression, unacceptable toxicity, or up to 24 months for some indications. Premedication is not routinely required. No dose adjustment for renal or hepatic impairment per label (mAb catabolism). Hold for G2-3 immune-related AE; permanently discontinue for G4 irAE, recurrent G3, myocarditis, or any life-threatening reaction. Treat irAE per ASCO / NCCN / ESMO algorithm (high-dose corticosteroids, escalate to infliximab / mycophenolate / IVIG for steroid-refractory). |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-27 |
Notes
Generally interchangeable with pembrolizumab in PD-L1-high NSCLC 1L per cross-trial efficacy comparisons. Unique niches are advanced cutaneous SCC (first systemic approval; durable responses ~50%) and post-Hh BCC. Baseline workup before first dose: TFTs (TSH + free T4), LFTs, creatinine, cortisol (AM), HbA1c, troponin if cardiac history, HBV/HCV serology, baseline imaging, dermatologic + pulmonary review. Monitor TFTs, LFTs, creatinine before each dose for first 6 cycles then q2 cycles. Refer for ophthalmology / cardiology / endocrinology consultation at first sign of organ-specific irAE. Hospitalize and start high-dose IV methylprednisolone for any G3-4 irAE; consult guidelines for refractory cases. In UA ICI access is dominated by pembrolizumab under НСЗУ; cemiplimab access is via EAP / cross-border / self-pay.
Used By
No reverse references found in the YAML corpus.