Last reviewed 2026-04-19 · How we verify

Vizimpro (Dacomitinib)

Irreversible pan-HER kinase inhibitor targeting EGFR, HER2, HER4, and EGFR-activating mutations.

Vizimpro (dacomitinib) is an irreversible pan-HER inhibitor approved by the FDA for first-line treatment of metastatic NSCLC harboring EGFR-activating mutations (exon 19 deletion or L858R). As a pan-HER inhibitor, it provides broader kinase coverage than first-generation EGFR TKIs, potentially reducing resistance mechanisms. The drug demonstrates clinical efficacy in both subcutaneous and intracranial tumor models. Dacomitinib targets EGFR/HER1, HER2, and HER4, with additional activity against DDR1, EPHA6, LCK, DDR2, and MNK1 at therapeutic concentrations. Its irreversible binding mechanism and multi-target profile position it as a best-in-class option for EGFR-mutant NSCLC.

At a glance

Mechanism of action

Dacomitinib is an irreversible inhibitor of the human EGFR family kinases, including EGFR/HER1, HER2, and HER4. It specifically targets tumors driven by EGFR-activating mutations, particularly exon 19 deletions and the exon 21 L858R substitution mutation. The irreversible binding mechanism covalently modifies the ATP-binding pocket, providing sustained kinase inhibition and potentially overcoming resistance mechanisms that develop with reversible inhibitors. Beyond the HER family, dacomitinib exhibits off-target activity against DDR1, EPHA6, LCK, DDR2, and MNK1 at clinically relevant concentrations. This broader kinase inhibition profile may contribute to its clinical efficacy and potentially reduce the emergence of bypass pathway resistance. The pan-HER approach addresses the limitation of first-generation EGFR TKIs, which are susceptible to HER2-mediated resistance. Preclinical studies demonstrate dose-dependent inhibition of EGFR and HER2 autophosphorylation with corresponding tumor growth suppression in xenograft models. Notably, dacomitinib shows antitumor activity in intracranial xenografts driven by EGFR amplifications, suggesting adequate CNS penetration—a clinically relevant advantage for patients with brain metastases.

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
• Conjunctivitis
• Nasal mucosal disorder

Drug interactions

• Proton Pump Inhibitors (PPIs)
• H2-receptor antagonists
• Locally-acting antacids
• CYP2D6 Substrates

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

Primary sources

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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 Inc. portfolio CI