{"entity":{"id":"lazertinib","kind":"drug","name":"Lazertinib","aka":[],"tldr":"A third-generation EGFR pill used together with amivantamab as the first regimen to beat osimertinib in EGFR-mutant lung cancer.","summary":"Developed by Yuhan, licensed to Janssen. Approved August 2024 only in combination with amivantamab (MARIPOSA: PFS HR 0.70; OS HR 0.75 with median >12 months longer than osimertinib, 2025). Rash, paronychia, and venous thromboembolism (prophylactic anticoagulation for 4 months) are the combination's main burdens.","status":"approved","asOf":"2026-09-06","wikipedia":"https://en.wikipedia.org/wiki/Lazertinib","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Lazertinib"},{"label":"NICE TA1122: amivantamab with lazertinib for untreated EGFR mutation-positive advanced non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1122"}],"tags":[],"related":["egfr-l858r"],"cancers":["nsclc","egfr-mutant-nsclc","lung-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["egfr"],"drugs":["amivantamab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":["mariposa","nct05388669","nct05498428","nct05663866","nct06667076","nct07586202","nct06120140","nct04988295","nct05541822"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Lazcluze","modality":"Small-molecule kinase inhibitor (EGFR)","mechanism":"Irreversible mutant-selective EGFR TKI (exon 19 del, L858R, T790M), CNS-penetrant.","approvals":[{"region":"US","year":2024,"indication":"First-line EGFR exon 19 del / L858R NSCLC with amivantamab"},{"region":"EU","year":2025,"indication":"1L EGFR-mutant NSCLC with amivantamab; 20 Jan 2025"},{"region":"England (NICE)","year":2026,"indication":"Untreated advanced EGFR mutation-positive non-small-cell lung cancer (exon 19 deletion or L858R), with amivantamab","note":"TA1122, published 21 January 2026, subject to the commercial arrangements for both drugs."}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/lazertinib/","neighbours":{"biomarker":[{"id":"egfr-exon-19-deletion","kind":"biomarker","name":"EGFR exon 19 deletion","route":"/biomarkers/egfr-exon-19-deletion/"},{"id":"egfr-l858r","kind":"biomarker","name":"EGFR L858R","route":"/biomarkers/egfr-l858r/"}],"cancer":[{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"drug":[{"id":"amivantamab","kind":"drug","name":"Amivantamab","route":"/drugs/amivantamab/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"trial":[{"id":"nct04988295","kind":"trial","name":"A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure","route":"/trials/nct04988295/"},{"id":"nct06667076","kind":"trial","name":"A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","route":"/trials/nct06667076/"},{"id":"nct05498428","kind":"trial","name":"A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer","route":"/trials/nct05498428/"},{"id":"nct05388669","kind":"trial","name":"A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)","route":"/trials/nct05388669/"},{"id":"nct07586202","kind":"trial","name":"A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC","route":"/trials/nct07586202/"},{"id":"chrysalis","kind":"trial","name":"CHRYSALIS","route":"/trials/chrysalis/"},{"id":"nct06120140","kind":"trial","name":"Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib","route":"/trials/nct06120140/"},{"id":"mariposa","kind":"trial","name":"MARIPOSA","route":"/trials/mariposa/"},{"id":"nct05663866","kind":"trial","name":"Premedication to Reduce Amivantamab Associated Infusion Related Reactions","route":"/trials/nct05663866/"},{"id":"nct05541822","kind":"trial","name":"To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation","route":"/trials/nct05541822/"}],"term":[{"id":"egfr-exon19-l858r","kind":"term","name":"EGFR exon 19 deletion & L858R","route":"/terms/egfr-exon19-l858r/"},{"id":"lung-uk-drug-access","kind":"term","name":"Lung cancer drugs in England: what NICE has recommended","route":"/terms/lung-uk-drug-access/"}],"pairing":[{"id":"amivantamab-plus-lazertinib","kind":"pairing","name":"Amivantamab + lazertinib (first-line EGFR NSCLC)","route":"/pairings/amivantamab-plus-lazertinib/"}],"person":[{"id":"cho-byoung-chul","kind":"person","name":"Byoung Chul Cho","route":"/people/cho-byoung-chul/"},{"id":"lee-dae-ho","kind":"person","name":"Dae Ho Lee","route":"/people/lee-dae-ho/"}],"paper":[{"id":"paper-mariposa-nejm-2024","kind":"paper","name":"MARIPOSA: amivantamab plus lazertinib versus osimertinib as first treatment for EGFR-mutated lung cancer","route":"/key-papers/paper-mariposa-nejm-2024/"}],"pathway":[{"id":"drug-tolerant-persisters","kind":"pathway","name":"Drug-tolerant persister cells","route":"/pathways/drug-tolerant-persisters/"},{"id":"nsclc-signalling","kind":"pathway","name":"Non-small cell lung cancer (KEGG map)","route":"/pathways/nsclc-signalling/"}],"roadmap":[{"id":"targeted-therapy-roadmap","kind":"roadmap","name":"Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall","route":"/roadmaps/targeted-therapy-roadmap/"}]}}