Cemiplimab 350mg/7ml solution for infusion vials
Requires a prescription from a doctor or prescriber
Cemiplimab is a fully human monoclonal antibody that works against programmed death receptor-1 (PD-1), which is a negative regulator of T cell function.
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Cemiplimab
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Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
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Suspected adverse reactions reported for Cemiplimab
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
MHRA licensed products
View all licensed products for Cemiplimab on the MHRA register
Libtayo 350mg/7ml concentrate for solution for infusion vials
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(6)
Cemiplimab for treating advanced cutaneous squamous cell carcinoma (TA802)
Cemiplimab with platinum-based chemotherapy for untreated advanced non-small-cell lung cancer (TA1165)
Cemiplimab for treating recurrent or metastatic cervical cancer (terminated appraisal) (TA901)
Cemiplimab for untreated PD-L1-positive advanced or metastatic non-small-cell lung cancer (terminated appraisal) (TA848)
Lung cancer: diagnosis and management (NG122)
Tisotumab vedotin for treating recurrent or metastatic cervical cancer that has progressed on or after systemic treatment (TA1164)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
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Supply & safety information
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Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 14 · Randomised trials: 5 · 2018–2026
Showing the 50 most relevant studies, sorted by most relevant.
Ahmet Sezer, Saadettin Kılıçkap, Mahmut Gümüş, et al.
The Lancet, 2021
- Pemetrexed
- Antineoplastic Agents, Immunological
- Progression-Free Survival
Miranda Gogishvili, Tamar Melkadze, Tamta Makharadze, et al.
Nature Medicine, 2022
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Antineoplastic Combined Chemotherapy Protocols
Mustafa Özgüroğlu, Saadettin Kılıçkap, Ahmet Sezer, et al.
The Lancet Oncology, 2023
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Pneumonia
S. Vasudevan, Tanisha Patel, John DiGiovanni, et al.
The Journal of investigative dermatology, 2025
M. Palomba, Julia Adriana Karmirski, F. Hojaij
International Journal of Molecular Sciences, 2025
- Carcinoma, Squamous Cell
- Skin Neoplasms
- Neoadjuvant Therapy
Abstract Skin cancer is the most common cancer form worldwide, and it is primarily divided into melanoma and non-melanoma types, with non-melanoma being the most prevalent condition. Cutaneous squamous cell carcinoma (cSCC) accounts for 50% of primary skin cancers and is characterized by uncontrolled keratinocyte proliferation. cSCC’s current standard treatment is surgical resection and chemotherapy. Unfortunately, these methods often lead to disfigurement, functional morbiditly, and compromised function. In contrast to immunotherapy, emerging scenarios have shown promising results, especially in neoadjuvant settings. Cemiplimab (Libtayo®; Regeneron, Tarrytown, NY, USA), a PD-1 monoclonal antibody, has shown efficacy in treating advanced or metastatic cSCC, and its use as a neoadjuvant therapy has been recently explored. This review aims to evaluate Cemiplimab in the neoadjuvant setting for cSCC treatment. The Methodology followed PRISMA guidelines, this review analyzed studies on Cemiplimab as a neoadjuvant therapy for cSCC that were sourced from PubMed, Web of Science, and Scopus. Only controlled trials, cohort studies, case series, and systematic reviews were included. From 341 records, 21 studies were included, and six clinical trials provided key data about neoadjuvant Cemiplimab’s response rates, efficacy, adverse effects, and safety considerations. The targeted data revealed a neoadjuvant Cemiplimab mean pathologic response rate of 72%, with a 62% objective response rate. Treatment-related adverse events (TRAEs) affect 66% of patients, though most cases are not severe. The most common include fatigue, maculopapular rash, and diarrhea. The studies showed high rates of complete pathological responses (cPRs) and major pathological responses (mPRs), suggesting a strong therapeutic potential. Neoadjuvant Cemiplimab for cSCC therapy shows high response rates, low recurrence, improved survival, and manageable side effects. The current literature indicates that Cemiplimab may also be effective when used in immunosuppressed patients. Despite more research still being needed to confirm its long-term benefits and the effects of the drug’s use outside of clinical trials, there is strong evidence to consider neoadjuvant Cemiplimab as a promising and efficient treatment.
Abstract licence: CC BY 4.0
Mane A, Yadav R
2025
Joly-Chevrier M, Aly S, Xie P, et al.
2026
H. AlKhalaf, Mohammed Youssef M AlZaid, Abdullelah Redn Almutairi
Journal of Clinical Case Studies Reviews & Reports, 2025
Michael R. Migden, Danny Rischin, Chrysalyne D. Schmults, et al.
New England Journal of Medicine, 2018
- Antibodies, Monoclonal
- Antineoplastic Agents
- Carcinoma, Squamous Cell
Michael R. Migden, Nikhil I. Khushalani, Anne Lynn S. Chang, et al.
The Lancet Oncology, 2020
- Antineoplastic Agents, Immunological
- Australia
- Carcinoma, Squamous Cell
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
20.3 days
Mechanism
T cells mediate antitumour activity following activation by antigen receptor sig…
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
1 mg/k
Half-life
20.3 days
[L39804]
Protein binding
Volume of distribution
5.3 L
[L39804]
Metabolism
[L43872]…
Elimination
Clearance
0.29 L
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Cemiplimab was first approved by the FDA on September 28, 2018, as the first FDA-approved treatment for advanced cutaneous squamous cell carcinoma (CSCC).[A39201][A254177][L4615] It was later approved to be used in basal cell carcinoma and non-small non-small cell lung cancer.[L39804] Cemiplimab was also approved by the European Commission on June 28, 2019.[L43872] In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended cemiplimab be granted marketing authorization for the treatment of cervical cancer.[L43867] The EMA then approved Libtayo (cemiplimab) for that indication later in the same year. [L43872]
- for the adjuvant treatment of adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.
[L54121]
- Locally advanced or metastatic cutaneous squamous cell carcinoma (mCSCC) in patients who are not candidates for curative surgery or curative radiation.
[L39804][L43872]
- Locally advanced basal cell carcinoma (laBCC) in previously treated patients with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.
[L39804][L43872]
- Metastatic basal cell carcinoma (mBCC) in patients who were previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. This indication is approved under accelerated approval based on tumour response rate and durability of response. Continued approval for mBCC may be contingent upon verification and description of clinical benefit.
[L39804][L43872]
- Locally advanced non-small cell lung cancer (NSCLC) in combination with platinum‐based chemotherapy for the first‐line treatment of adults with no EGFR, ALK or ROS1 aberrations, who are not candidates for surgical resection or definitive chemoradiation.
It is also indicated to treat metastatic NSCLC in combination with platinum‐based chemotherapy as first-line treatment in adults.
[L43902]
- Locally advanced or metastatic NSCLC as monotherapy for the first-line treatment of adults whose tumours have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations. Patients with locally advanced NSCLC must not be candidates for surgical resection or definitive chemoradiation.
[L43902]
- Recurrent or metastatic cervical cancer in adults with disease progression on or after platinum-based chemotherapy.
[L43872]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 417 interactions
[L43872]
PD-L1 and PD-L2 are expressed on antigen-presenting cells (APCs) as well as on some types of tumour cells [A254177][L43872] as part of an adaptive immune response by tumours.[A254177][A192801] PD-1 is also upregulated in some cancers, impeding T cell-mediated antitumour activity.[L39804] Cemiplimab is a human PD-1-blocking antibody that binds to PD-1 and blocks its interaction with its ligands. By disinhibiting PD-1 mediated suppression of T cell activity, cemiplimab works to potentiate T cell cytotoxicity against tumours.[L39804]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L39804]
Steady-state exposure is achieved after four months of treatment.
[L39804]
[L39804]
[L39804]
[L43872]
[L39804]
Proteins and enzymes this drug interacts with in the body
PMID:21276005 PMID:37208329
Delivers inhibitory signals upon binding to ligands CD274/PDCD1L1 and CD273/PDCD1LG2 .
PMID:21276005
Following T-cell receptor (TCR) engagement, PDCD1 associates with CD3-TCR in the immunological synapse and directly inhibits T-cell activation (By similarity). Suppresses T-cell activation through the recruitment of PTPN11/SHP-2: following ligand-binding, PDCD1 is phosphorylated within the ITSM motif, leading to the recruitment of the protein tyrosine phosphatase PTPN11/SHP-2 that mediates dephosphorylation of key TCR proximal signaling molecules, such as ZAP70, PRKCQ/PKCtheta and CD247/CD3zeta (By similarity)
ATC L01FF06
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Cemiplimab
DrugBank citations
If you use DrugBank data in your research, please cite the following publications: