{"entity":{"id":"dacomitinib","kind":"drug","name":"Dacomitinib","aka":[],"tldr":"A second-generation EGFR pill that beat gefitinib on survival in EGFR-mutant lung cancer but was quickly overshadowed by osimertinib.","summary":"Dacomitinib is a second-generation, irreversible pan-ErbB tyrosine kinase inhibitor that blocks EGFR, HER2 and HER4. In the ARCHER 1050 trial (2017 to 2018) it beat gefitinib in first-line EGFR-mutant NSCLC, with median progression-free survival of 14.7 versus 9.2 months and overall survival of 34.1 versus 26.8 months, although patients with brain metastases were excluded. It was approved in the US in 2018 and the EU in 2019 for first-line metastatic NSCLC with exon 19 deletion or L858R. Higher rates of rash, diarrhoea and paronychia mean most patients need dose reductions, which appear not to compromise efficacy. It was quickly overshadowed by osimertinib, which has CNS activity and better tolerability, so it is now seldom used. Dacomitinib remains one of the few EGFR inhibitors to have shown an overall survival gain over another EGFR inhibitor.","status":"approved","asOf":"2026-09-24","wikipedia":"https://en.wikipedia.org/wiki/Dacomitinib","links":[{"label":"ARCHER 1050 (Lancet Oncol 2017)","url":"https://doi.org/10.1016/S1470-2045(17)30608-3"},{"label":"ARCHER 1050 overall survival (JCO 2018)","url":"https://doi.org/10.1200/JCO.2018.78.7994"},{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=dacomitinib"},{"label":"NICE TA595: dacomitinib for untreated EGFR mutation-positive non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta595"}],"tags":["gap-fill"],"related":["egfr-exon-19-deletion"],"cancers":["nsclc","lung-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["egfr"],"drugs":[],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":["nct01774721","nct01360554","nct06486142"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Vizimpro","modality":"Small-molecule pan-ErbB TKI (second generation, irreversible)","mechanism":"Irreversible inhibitor of EGFR, HER2 and HER4.","approvals":[{"region":"US","year":2018,"indication":"First-line metastatic NSCLC with EGFR exon 19 del or L858R"},{"region":"EU","year":2019,"indication":"Same"},{"region":"England (NICE)","year":2019,"indication":"Untreated locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer","note":"TA595, published 14 August 2019, subject to the commercial arrangement (ARCHER 1050)."}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/dacomitinib/","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":"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/"},{"id":"erbb4","kind":"target","name":"HER4 (ERBB4)","route":"/targets/erbb4/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}],"trial":[{"id":"nct01360554","kind":"trial","name":"ARCHER 1009: A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer","route":"/trials/nct01360554/"},{"id":"nct01774721","kind":"trial","name":"ARCHER 1050","route":"/trials/nct01774721/"},{"id":"nct06486142","kind":"trial","name":"EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study","route":"/trials/nct06486142/"}],"term":[{"id":"lung-uk-drug-access","kind":"term","name":"Lung cancer drugs in England: what NICE has recommended","route":"/terms/lung-uk-drug-access/"}],"paper":[{"id":"paper-archer-1050-lancet-oncol-2017","kind":"paper","name":"Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial","route":"/key-papers/paper-archer-1050-lancet-oncol-2017/"},{"id":"paper-archer-1050-os-jco-2018","kind":"paper","name":"Improvement in overall survival in a randomized study that compared dacomitinib with gefitinib in patients with advanced non-small-cell lung cancer and EGFR-activating mutations","route":"/key-papers/paper-archer-1050-os-jco-2018/"}]}}