Last reviewed · How we verify
Vizimpro (dacomitinib)
Vizimpro works by blocking the EGFR tyrosine kinase, a protein that helps cancer cells grow and survive.
Vizimpro (dacomitinib) is a small molecule drug developed by Pfizer that targets the epidermal growth factor receptor (EGFR) in non-small cell lung cancer (NSCLC) cells. It was approved by the FDA in 2018 for the treatment of EGFR mutation-positive, unresectable or recurrent NSCLC. Vizimpro works by inhibiting the EGFR tyrosine kinase, which is involved in the signaling pathways that promote cancer cell growth and survival. The drug is patented and has not yet gone generic. Key safety considerations include its potential to cause severe diarrhea, rash, and liver damage.
At a glance
| Generic name | dacomitinib |
|---|---|
| Sponsor | Pfizer |
| Target | Epidermal growth factor receptor |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2018 |
Mechanism of action
Dacomitinib is an irreversible inhibitor of the kinase activity of the human EGFR family (EGFR/HER1, HER2, and HER4) and certain EGFR activating mutations (exon 19 deletion or the exon 21 L858R substitution mutation). In vitro dacomitinib also inhibited the activity of DDR1, EPHA6, LCK, DDR2, and MNK1 at clinically relevant concentrations.Dacomitinib demonstrated dose-dependent inhibition of EGFR and HER2 autophosphorylation and tumor growth in mice bearing subcutaneously implanted human tumor xenografts driven by HER family targets including mutated EGFR. Dacomitinib also exhibited antitumor activity in orally-dosed mice bearing intracranial human tumor xenografts driven by EGFR amplifications.
Approved indications
- EGFR mutation-positive, unresectable or recurrent non-small cell lung cancer
- Non-small cell lung cancer, positive for epidermal growth factor receptor expression
Common side effects
- Diarrhea
- Rash
- Paronychia
- Stomatitis
- Decreased appetite
- Dry skin
- Decreased weight
- Alopecia
- Cough
- Pruritus
- Interstitial lung disease
- Nausea
Key clinical trials
- Korea Post Marketing Surveillance (PMS) Study of Vizimpro
- Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer (PHASE1)
- Cancer Therapy-Related Cardiac Dysfunction Associated With EGFR-TKIs in Advanced EGFR-mutant Non-small Cell Lung Cancer
- Dacomitinib in Lung Cancer With Uncommon EGFR Mutations (PHASE2)
- A Study to Learn About Dacomitinib in Patients With Non-small Cell Lung Cancer.
- Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC (PHASE1,PHASE2)
- Phase 2 Study of Dacomitinib in NSCLC (PHASE2)
- Phase-2 Dacomitinib Study on Patients With EGFR-Driven Advanced Solid Tumours With Low EGFR-AS1 IncRNA Expr or Other Novel Emerging Biomarkers (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vizimpro CI brief — competitive landscape report
- Vizimpro updates RSS · CI watch RSS
- Pfizer portfolio CI