{"entity":{"id":"cemiplimab","kind":"drug","name":"Cemiplimab","aka":[],"tldr":"A PD-1 blocker that is the standard for advanced skin squamous cell carcinoma, and in 2025 became the first adjuvant immunotherapy for it.","summary":"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.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Cemiplimab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Cemiplimab"},{"label":"NICE TA1165: cemiplimab with platinum-based chemotherapy for untreated advanced non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1165"}],"tags":[],"related":["pd-l1-tps"],"cancers":["nsclc","melanoma","pdl1-high-nsclc","cutaneous-scc","advanced-cutaneous-scc","lip-cancer","basal-cell-carcinoma","locally-advanced-bcc","cervical","recurrent-metastatic-cervical-cancer","lung-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":[],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":["skin-cancer-after-organ-transplant"],"trials":["nct06246916","nct05800015","nct06585410","nct05317858","nct05608291","nct05785767","nct03972657","nct04050436","nct06463665","nct05557591","nct04291105","nct06162572","nct06161441","nct03916627","nct06190951","nct07594106","nct06413680","nct06769698","nct04305795","nct06908304","nct06384807","nct04626635","nct05208944","nct03491683","empower-lung-1","c-post","neoadjuvant-cemiplimab-cscc","cemiplimab-advanced-bcc","cemiplimab-kidney-transplant-cscc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Libtayo","modality":"Monoclonal antibody (anti-PD-1)","mechanism":"Human IgG4 anti-PD-1.","approvals":[{"region":"US","year":2018,"indication":"Advanced cutaneous squamous cell carcinoma"},{"region":"US","year":2025,"indication":"Adjuvant high-risk CSCC after surgery and radiation"},{"region":"England (NICE)","year":2026,"indication":"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","note":"TA1165, published 16 June 2026, as an option where pembrolizumab with platinum-based chemotherapy would otherwise be offered."}],"mechanismSteps":["Antibody binds PD-1","PD-1/PD-L1 engagement between T cell and tumour is blocked","Exhausted tumour-reactive T cells regain effector function","Interferon-γ and cytotoxic granules are released at the tumour","Tumour cells are killed; memory T cells persist"],"dosing":{"route":"IV infusion","schedule":"350 mg every 3 weeks","modifications":"Standard immune-mediated event algorithm","monitoring":"Thyroid, LFTs, creatinine, skin","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},"toxicity":[{"event":"Fatigue"},{"event":"Musculoskeletal pain"},{"event":"Rash"},{"event":"Diarrhoea"},{"event":"Anaemia"},{"event":"Hypothyroidism"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","assistance":"https://www.libtayosurroundcare.com","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended for advanced cutaneous squamous cell carcinoma (TA592) and PD-L1 ≥50% NSCLC","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2018-09-28","type":"approval","region":"US","note":"Advanced cutaneous squamous cell carcinoma: first systemic therapy approved for CSCC","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2021-02-09","type":"accelerated-approval","region":"US","note":"Advanced basal cell carcinoma after hedgehog inhibitor","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Patients with metastatic basal cell carcinoma (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate"},{"date":"2021-02-22","type":"approval","region":"US","note":"First-line PD-L1 ≥50% NSCLC (EMPOWER-Lung 1)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2023-04-28","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2021 converted to traditional approval 2.2 years after it was granted.","indication":"Patients with metastatic basal cell carcinoma (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate"},{"date":"2025-10","type":"approval","region":"US","note":"Adjuvant high-risk CSCC after surgery and radiation (C-POST)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/cemiplimab/","neighbours":{"biomarker":[{"id":"pd-l1-tps","kind":"biomarker","name":"PD-L1 TPS (tumour proportion score)","route":"/biomarkers/pd-l1-tps/"}],"cancer":[{"id":"advanced-cutaneous-scc","kind":"cancer","name":"Advanced cutaneous squamous cell carcinoma","route":"/cancers/advanced-cutaneous-scc/"},{"id":"basal-cell-carcinoma","kind":"cancer","name":"Basal cell carcinoma","route":"/cancers/basal-cell-carcinoma/"},{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"cutaneous-scc","kind":"cancer","name":"Cutaneous squamous cell carcinoma","route":"/cancers/cutaneous-scc/"},{"id":"hpv-independent-vulvar-cancer","kind":"cancer","name":"HPV-independent vulvar squamous cell carcinoma (p53-mutant)","route":"/cancers/hpv-independent-vulvar-cancer/"},{"id":"lip-cancer","kind":"cancer","name":"Lip cancer","route":"/cancers/lip-cancer/"},{"id":"locally-advanced-bcc","kind":"cancer","name":"Locally advanced and metastatic basal cell carcinoma","route":"/cancers/locally-advanced-bcc/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"node-positive-penile-cancer","kind":"cancer","name":"Node-positive and metastatic penile cancer","route":"/cancers/node-positive-penile-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"pdl1-high-nsclc","kind":"cancer","name":"PD-L1-high non-small-cell lung cancer without a driver mutation","route":"/cancers/pdl1-high-nsclc/"},{"id":"penile","kind":"cancer","name":"Penile cancer","route":"/cancers/penile/"},{"id":"recurrent-metastatic-cervical-cancer","kind":"cancer","name":"Recurrent or metastatic cervical cancer","route":"/cancers/recurrent-metastatic-cervical-cancer/"},{"id":"skin-cancer","kind":"cancer","name":"Skin cancer (all types)","route":"/cancers/skin-cancer/"},{"id":"lung-squamous-cell-carcinoma","kind":"cancer","name":"Squamous cell carcinoma of the lung","route":"/cancers/lung-squamous-cell-carcinoma/"},{"id":"vulvar","kind":"cancer","name":"Vulvar cancer","route":"/cancers/vulvar/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"company":[{"id":"maia-biotechnology","kind":"company","name":"Maia Biotechnology","route":"/companies/maia-biotechnology/"},{"id":"regeneron","kind":"company","name":"Regeneron","route":"/companies/regeneron/"}],"term":[{"id":"lung-uk-drug-access","kind":"term","name":"Lung cancer drugs in England: what NICE has recommended","route":"/terms/lung-uk-drug-access/"},{"id":"skin-cancer-after-organ-transplant","kind":"term","name":"Skin cancer after an organ transplant","route":"/terms/skin-cancer-after-organ-transplant/"},{"id":"squamous-cell-carcinoma","kind":"term","name":"Squamous cell carcinoma","route":"/terms/squamous-cell-carcinoma/"},{"id":"hedgehog-inhibitor-tolerability","kind":"term","name":"Why people stop taking hedgehog inhibitors","route":"/terms/hedgehog-inhibitor-tolerability/"}],"trial":[{"id":"nct06931717","kind":"trial","name":"A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Re","route":"/trials/nct06931717/"},{"id":"nct06413680","kind":"trial","name":"A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Hav","route":"/trials/nct06413680/"},{"id":"nct06412198","kind":"trial","name":"A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations","route":"/trials/nct06412198/"},{"id":"nct06384807","kind":"trial","name":"A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced 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