NDAORALTABLETPriority Review
Approved
Sep 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIZIMPRO (dacomitinib) is an oral small-molecule tyrosine kinase inhibitor approved by the FDA in September 2018. It is indicated for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Dacomitinib irreversibly inhibits EGFR and HER2 kinase activity, providing dual pathway blockade.
$3.0MPart D
Peak6.3 years to LOEProduct is in peak lifecycle phase with modest Part D utilization; commercial team is likely stabilized with focus on market access and physician education rather than rapid growth.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Learn About Dacomitinib in Patients With Non-small Cell Lung Cancer.
Started Jul 2024
29 enrolled
Lung Cancer
Phase-2 Dacomitinib Study on Patients With EGFR-Driven Advanced Solid Tumours With Low EGFR-AS1 IncRNA Expr or Other Novel Emerging Biomarkers
Started Aug 2021
24 enrolled
Advanced Solid TumoursNon-small Cell Lung CancerHead and Neck Squamous Cell Carcinoma
Real World Utilization and Outcomes With Dacomitinib First Line Treatment for EGFR Mutation-positive Advanced Non Small Cell Lung Cancer Among Asian Patients - A Multi Center Chart Review
Started Jun 2021
307 enrolled
Lung Cancer
Korea Post Marketing Surveillance (PMS) Study of Vizimpro
Started Mar 2021
188 enrolled
Lung Neoplasms
Dacomitinib Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced NSCLC
Started Sep 2020
82 enrolled
EGFR Activating MutationNSCLC Stage IVNSCLC Stage IIIB+1 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.