VIZIMPRO (dacomitinib)
Vizimpro (dacomitinib) is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
How VIZIMPRO Works
Dacomitinib is an irreversible inhibitor of the tyrosine kinase activity of the human EGFR family (EGFR/HER1, HER2, and HER4) and specific EGFR activating mutations (exon 19 deletion or exon 21 L858R substitution). By binding covalently to the ATP-binding site, dacomitinib inhibits receptor autophosphorylation and downstream signaling pathways responsible for tumor cell proliferation and survival. It has also demonstrated inhibition of other kinases, including DDR1, EPHA6, and LCK, at clinically relevant concentrations.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-09-27
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- TABLET
VIZIMPRO Approval History
What VIZIMPRO Treats
1 indicationsVIZIMPRO is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
VIZIMPRO Target & Pathway
ProTarget
A receptor tyrosine kinase that promotes cell growth and division. Approximately 20% of breast cancers overexpress HER2, leading to aggressive tumor growth. Targeting HER2 blocks these growth signals and can trigger immune-mediated destruction of cancer cells.
Pathway Context
HER2 forms dimers with other HER family members to activate growth signaling
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
VIZIMPRO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in VIZIMPRO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VIZIMPRO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to VIZIMPRO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03810807 | 18-411 | Ph 1 | completed | Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer |
| NCT04504071 | LS2034 | Ph 2 | active not recruiting | Dacomitinib in Lung Cancer With Uncommon EGFR Mutations |
| NCT02039336 M13DAP | NL45985.031.13 | Ph 1, Ph 2 | completed | Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC |
| NCT04027647 | ATORG-003 | Ph 2 | active not recruiting | Phase 2 Study of Dacomitinib in NSCLC |
| NCT04511533 results posted | A7471064 | Ph 4 | completed | Dacomitinib for Treatment of Patients in India With Metastatic Non Small Cell Lung Cancer With EGFR Activating Mutations |
| NCT03878524 | STUDY00015588 NCI-2020-02743, STUDY00015588 | Ph 1 | terminated | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial |
| NCT02925234 DRUP | M15DRU | Ph 2 | recruiting | The Drug Rediscovery Protocol (DRUP Trial) |
| NCT05271916 | IS22001 | Ph 1, Ph 2 | recruiting | First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations |
| NCT01920061 results posted | B2151002 2013-001390-24 | Ph 1 | completed | A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC) |
| NCT01728233 HER-Uro01 | INT110/12 | Ph 2 | completed | Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis |
| NCT03865446 results posted | A7471058 | Ph 1 | completed | Evaluate Severe Hepatic Impairment on Dacomitinib PK |
| NCT02382796 results posted | A7471055 | Ph 2 | completed | A Rollover Protocol of Dacomitinib For Patients In Japan |
| NCT01465802 ARCHER 1042 results posted | A7471042 | Ph 2 | completed | Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO |
| NCT01858389 results posted | A7471047 | Ph 2 | completed | A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer |
| NCT02047747 results posted | 130418 | Ph 2 | terminated | A Phase II Study of Dacomitinib in Progressive Brain Metastases |
| NCT01737008 | XDC-001 | Ph 1 | completed | Dacomitinib Plus Radiotherapy, With and Without Cisplatin in Patients With Squamous Cell Carcinoma of the Head and Neck |
| NCT02097433 | A7471051 | Ph 1 | completed | Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers |
| NCT01571388 | A7471018 | Ph 1 | completed | A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VIZIMPRO FDA Label Details
Indications & Usage
FDA Label (PDF)VIZIMPRO is indicated for the treatment of Non-Small Cell Lung Cancer.
Pro Intelligence Preview
Deep insights for VIZIMPRO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 27 active patents
Trial Analysis
- • 22 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment