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A PD-1 blocker that is the standard for advanced skin squamous cell carcinoma, and in 2025 became the first adjuvant immunotherapy for it.
Cemiplimab is a fully human IgG4 antibody against PD-1 that restores the activity of exhausted tumour-reactive T cells, given as a flat 350 mg infusion every 3 weeks. It was the first systemic therapy approved for advanced cutaneous squamous cell carcinoma (2018) and remains the standard there, and in 2025 it became the first adjuvant immunotherapy for high-risk cutaneous squamous cell carcinoma after surgery and radiation, based on C-POST. It is also approved for advanced basal cell carcinoma after a hedgehog inhibitor (2021) and for first-line NSCLC with PD-L1 of 50 percent or more (EMPOWER-Lung 1, 2021). Developed by Regeneron with Sanofi, it shares the class profile of fatigue, musculoskeletal pain, rash, diarrhoea and hypothyroidism. Selecting skin cancer patients for adjuvant therapy remains open. It gave advanced skin squamous cell carcinoma its first effective drug.
Backbone ribbon from PDB 8GY5. RCSB PDB 8GY5. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
Human IgG4 anti-PD-1. Connects to PD-1.
1.Antibody binds PD-1
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
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.
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.
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.
Sources: NICE TA802 · SMC advice: cemiplimab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Advanced cutaneous squamous cell carcinoma: first systemic therapy approved for CSCC source
Patients with metastatic basal cell carcinoma (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate
Advanced basal cell carcinoma after hedgehog inhibitor source
First-line PD-L1 ≥50% NSCLC (EMPOWER-Lung 1) source
Patients with metastatic basal cell carcinoma (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate
Confirmed: the accelerated approval of 2021 converted to traditional approval 2.2 years after it was granted.
Adjuvant high-risk CSCC after surgery and radiation (C-POST) source
| Region | Year | Indication |
|---|---|---|
| US | 2018 | Advanced cutaneous squamous cell carcinoma |
| US | 2025 | Adjuvant high-risk CSCC after surgery and radiation |
| England (NICE) | 2026 | Untreated locally advanced non-small-cell lung cancer unsuitable for definitive chemoradiation, or metastatic disease, with PD-L1 in 1 percent or more of tumour cells and no EGFR or ALK alteration, with platinum-based chemotherapy · TA1165, published 16 June 2026, as an option where pembrolizumab with platinum-based chemotherapy would otherwise be offered. |
| 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.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | libtayosurroundcare.com |
| United Kingdom | NICE: recommended for advanced cutaneous squamous cell carcinoma (TA592) and PD-L1 ≥50% NSCLC | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Adjuvant cemiplimab is a new standard for high-risk cutaneous squamous cell carcinoma after surgery and radiotherapy, particularly in patients with extracapsular nodal extension.
Cemiplimab is an option for second-line cervical cancer in patients who have not had immunotherapy, though most now receive pembrolizumab first line, moving cemiplimab later or out of sequence.
Neoadjuvant cemiplimab is now used to shrink large or function-threatening cutaneous squamous cell carcinomas before surgery, and pathological response is being studied as a guide to omitting adjuvant radiotherapy.
Cemiplimab is approved for advanced basal cell carcinoma after hedgehog inhibitor therapy, adding immunotherapy to the pathway for this common but rarely advanced skin cancer.
PD-1 blockade is the first-line systemic treatment for advanced cutaneous squamous cell carcinoma, including on the lip, and cemiplimab has since moved into neoadjuvant and adjuvant use.
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.
Shares A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Ce, A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers, A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal, Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer.
Shares Cemiplimab for kidney transplant recipients with advanced skin squamous cell carcinoma, Neoadjuvant cemiplimab for resectable stage II to IV skin squamous cell carcinoma, Cemiplimab in basal cell carcinoma after a hedgehog inhibitor, Skin cancer after an organ transplant.
Shares EMPOWER-Cervical 1 / GOG-3016 / ENGOT-cx9, Neoadjuvant cemiplimab for resectable stage II to IV skin squamous cell carcinoma, Cemiplimab in basal cell carcinoma after a hedgehog inhibitor, C-POST (cemiplimab after surgery and radiotherapy for high-risk skin squamous cell carcinoma).
Shares Neoadjuvant cemiplimab for resectable stage II to IV skin squamous cell carcinoma, C-POST (cemiplimab after surgery and radiotherapy for high-risk skin squamous cell carcinoma), Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma.
Shares A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamata, Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent, Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer, Regeneron.