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Dacomitinib

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Also known as Vizimpro

PFIZER INC PFE · Non-Small Cell Lung Cancer; Non-small Cell Lung Cancer With EGFR-Activating Mutations

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Approved

    Not recorded

  • Linked trials

    2

    From ClinicalTrials.gov

  • Latest FDA action

    Approved

    NDA211288,

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
PFIZER INC PFE Source: Company record for PFIZER INC (opens in a new tab)
Indications
Non-Small Cell Lung Cancer; Non-small Cell Lung Cancer With EGFR-Activating Mutations Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Application
NDA 211288 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 211288 (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 CompletedFirst trial start 16 Jun 20112 linked trials
  5. Filed Completed
  6. Approved Current stageFirst approval 27 Sep 2018

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Dacomitinib. Editors add each one with its source.

Filed application

No filed application is on record for Dacomitinib. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Dacomitinib.

Clinical trials

Trials linked to Dacomitinib
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT01774721ClinicalTrials.gov record for NCT01774721 (opens in a new tab)ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.Phase 3Completed452 (actual)29 Jul 2016 (actual) Yes First posted Results on ClinicalTrials.gov for NCT01774721 (opens in a new tab)

Posted results on ClinicalTrials.gov for NCT01774721

  • Progression Free Survival (PFS) Based on Independent Radiologic Central (IRC) Review (months)
    • Dacomitinib vs Gefitinib: Hazard Ratio (HR) 0.589 (95% CI 0.469 to 0.739), p-value <0.0001, 1-sided stratified log-rank test, superiority

Serious adverse events (From randomization until death or last date known as alive, up to 91 months): Dacomitinib 69 of 227; Gefitinib 53 of 224; Dacomitinib (Ongoing at DCO) 4 of 11

Source: ClinicalTrials.gov results for NCT01774721 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing NCT01774721 (9), newest first

  1. Efficacy in patients with EGFR-positive non-small-cell lung cancer treated with dacomitinib who had skin adverse events: post hoc analyses from ARCHER 1050.

    Future oncology (London, England) · 2024

    PubMed 39360943 (opens in a new tab)DOI 10.1080/14796694.2024.2404762 (opens in a new tab)

  2. Evaluation of the Effect of Proton Pump Inhibitors on the Efficacy of Dacomitinib and Gefitinib in Patients with Advanced Non-Small Cell Lung Cancer and EGFR-Activating Mutations.

    Oncology and therapy · 2021 Dec

    PubMed 34120312 (opens in a new tab)DOI 10.1007/s40487-021-00156-2 (opens in a new tab)

  3. Safety and efficacy of first-line dacomitinib in Asian patients with EGFR mutation-positive non-small cell lung cancer: Results from a randomized, open-label, phase 3 trial (ARCHER 1050).

    Lung cancer (Amsterdam, Netherlands) · 2021 Apr

    PubMed 33721611 (opens in a new tab)DOI 10.1016/j.lungcan.2021.02.025 (opens in a new tab)

  4. Updated Overall Survival in a Randomized Study Comparing Dacomitinib with Gefitinib as First-Line Treatment in Patients with Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations.

    Drugs · 2021 Feb

    PubMed 33331989 (opens in a new tab)DOI 10.1007/s40265-020-01441-6 (opens in a new tab)

  5. Effects of dose modifications on the safety and efficacy of dacomitinib for EGFR mutation-positive non-small-cell lung cancer.

    Future oncology (London, England) · 2019 Aug

    PubMed 31313942 (opens in a new tab)DOI 10.2217/fon-2019-0299 (opens in a new tab)

All 9 publications for NCT01774721

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT01360554ClinicalTrials.gov record for NCT01360554 (opens in a new tab)ARCHER 1009ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung CancerPhase 3Completed878 (actual)30 Sep 2013 (actual) Yes First posted Results on ClinicalTrials.gov for NCT01360554 (opens in a new tab)

Posted results on ClinicalTrials.gov for ARCHER 1009

  • Progression-Free Survival (PFS) Per Independent Radiologic Review. (Months)
    • Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) vs Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo): Hazard Ratio (HR) 0.933 (95% CI 0.797 to 1.093), p-value 0.195, 1-sided stratified log-rank test, superiority or other
  • Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants. (Months)
    • Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) vs Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo): Hazard Ratio (HR) 1.037 (95% CI 0.848 to 1.268), p-value 0.643, 1-sided stratified log-rank test, superiority or other

Serious adverse events (AE reporting period is from 1st dose of study drug through 28 days after last dose of study drug. SAE reporting period is from informed consent through 28 days after last dose of study drug. The longest duration of treatment in this study was 48 weeks.): Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) 178 of 436; Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) 169 of 436

Source: ClinicalTrials.gov results for NCT01360554 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing ARCHER 1009 (3), newest first

  1. Targeting Cancer Cachexia: A Mechanistic Evaluation of Anti-GDF-15 Antibody-Based Combination Therapies.

    Journal of cachexia, sarcopenia and muscle · 2026 Jun

    PubMed 42126170 (opens in a new tab)DOI 10.1002/jcsm.70312 (opens in a new tab)

  2. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials.

    Annals of oncology : official journal of the European Society for Medical Oncology · 2016 Mar

    PubMed 26768165 (opens in a new tab)DOI 10.1093/annonc/mdv593 (opens in a new tab)

  3. Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): a randomised, double-blind, phase 3 trial.

    The Lancet. Oncology · 2014 Nov

    PubMed 25439691 (opens in a new tab)DOI 10.1016/S1470-2045(14)70452-8 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

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FDA actions

Original approvals and new-indication supplements for Dacomitinib, newest first
ApplicationActionDateOutcomeReviewSource
NDA211288Action letter for NDA211288 (opens in a new tab) Original 1 Type 1 - New Molecular EntityApprovedpriorityDrugs@FDA via openFDA (opens in a new tab)

Data provided by the U.S. Food and Drug Administration.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

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EU status (EMA)

Authorised

Vizimpro (EMEA/H/C/004779)

Authorised
Therapeutic area
Carcinoma, Non-Small-Cell Lung
Marketing authorisation holder
Pfizer Europe MA EEIG
Active substance (INN)
dacomitinib
ATC code
L01EB07
Latest EMA decision

Matched by active substance: EMA's INN or active substance equals this drug's name.

EMA page for Vizimpro (opens in a new tab)EMA medicine data (opens in a new tab)

Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.

Related news

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Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.