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A second-generation EGFR pill that beat gefitinib on survival in EGFR-mutant lung cancer but was quickly overshadowed by osimertinib.
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.
Irreversible inhibitor of EGFR, HER2 and HER4. Connects to EGFR.
1.Dacomitinib slips into a pocket on EGFR.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA595 · SMC advice: dacomitinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Region | Year | Indication |
|---|---|---|
| US | 2018 | First-line metastatic NSCLC with EGFR exon 19 del or L858R |
| EU | 2019 | Same |
| England (NICE) | 2019 | Untreated locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer · TA595, published 14 August 2019, subject to the commercial arrangement (ARCHER 1050). |
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This is the separate paper behind the survival figure quoted for dacomitinib. It is a real but modest gain, and the US label notes that overall survival was not formally tested because the response rate comparison earlier in the testing order was not significant, so the P value is descriptive.
ARCHER 1050 supported dacomitinib's 2018 US first-line approval and was the first head-to-head win of a second-generation EGFR inhibitor over a first-generation one on progression-free survival. FLAURA, reported the same year, made osimertinib the usual first choice, so dacomitinib is now rarely used.
Query for this drug: (TITLE:"Dacomitinib" OR ABSTRACT:"Dacomitinib" OR TITLE:"Vizimpro" OR ABSTRACT:"Vizimpro") 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 Dacomitinib, not a curated reading list.
Shares EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study, HER4 (ERBB4), EGFR L858R, EGFR exon 19 deletion.
Shares 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, 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, ARCHER 1050, EGFR L858R.
Shares ARCHER 1050, EGFR L858R, EGFR exon 19 deletion, EGFR.
Shares 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, 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, ARCHER 1050, EGFR.
Shares 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, 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, ARCHER 1050, Non-small-cell lung cancer.
Shares EGFR L858R, EGFR exon 19 deletion, EGFR, Non-small-cell lung cancer.
Shares EGFR L858R, EGFR exon 19 deletion, EGFR, Non-small-cell lung cancer.
Shares EGFR L858R, EGFR exon 19 deletion, Lung cancer drugs in England: what NICE has recommended, EGFR.