OnCo
drugsProductApproved2018🇪🇺🇬🇧🇯🇵🇦🇺

Cemiplimab

A PD-1 blocker that is the standard for advanced skin squamous cell carcinoma, and in 2025 became the first adjuvant immunotherapy for it.

Approved in cutaneous squamous cell carcinoma (2018; adjuvant 2025 based on C-POST), basal cell carcinoma, and NSCLC. Regeneron/Sanofi.

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Cemiplimab Fab bound to PD-1 (PDB 8GY5), backbone trace
RCSB PDB
How it works, step by step · animated schematic, not to scale
Immune checkpoint inhibitors
Mechanism, step by step
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1.Antibody binds PD-1

Modality
Monoclonal antibody (anti-PD-1)
Mechanism
Human IgG4 anti-PD-1.
Brand / code
Libtayo
Dosing & schedule
Route
IV infusion
Schedule
350 mg every 3 weeks
Dose modifications
Standard immune-mediated event algorithm
Monitoring
Thyroid, LFTs, creatinine, skin

Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.

Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies.

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.

Assistance programmes

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Cancer Drugs FundNICE TA592 · 2019SMC: accepted
Appraised for
Advanced cutaneous squamous cell carcinoma
Notes
Also PD-L1 ≥50% NSCLC (TA770, 2022).
Cancer Drugs Fund
Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA592 · NHS England Cancer Drugs Fund list · SMC advice: cemiplimab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 28 Sept 2018ApprovalUS

    Advanced cutaneous squamous cell carcinoma: first systemic therapy approved for CSCC source

  2. 9 Feb 2021ApprovalUS

    Advanced basal cell carcinoma after hedgehog inhibitor source

  3. 22 Feb 2021ApprovalUS

    First-line PD-L1 ≥50% NSCLC (EMPOWER-Lung 1) source

  4. Oct 2025ApprovalUS

    Adjuvant high-risk CSCC after surgery and radiation (C-POST) source

Approvals

RegionYearIndication
US2018Advanced cutaneous squamous cell carcinoma
US2025Adjuvant high-risk CSCC after surgery and radiation

Safety

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Toxicity profile
Adverse event
Fatigue
Musculoskeletal pain
Rash
Diarrhoea
Anaemia
Hypothyroidism

Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.

Cost & access

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Cost & access
CountryReimbursement
United StatesMedicare Part B (physician-administered); commercial plans per formulary
United KingdomNICE: recommended for advanced cutaneous squamous cell carcinoma (TA592) and PD-L1 ≥50% NSCLC

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
174 studies42 recruiting92 Phase 211 Phase 3
Search “Cemiplimab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Cemiplimab
intervention: Cemiplimab
Open on ClinicalTrials.gov →

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Latest papers

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Literature trend140 papers in the last 12 months+15% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Cemiplimab" OR ABSTRACT:"Cemiplimab" OR TITLE:"Libtayo" OR ABSTRACT:"Libtayo") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Cemiplimab, not a curated reading list.

Connected

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