Dacomitinib

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.

• VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.ICD-10: C34.90

• None. None.contraindicated

Recommended Dosage: 45 mg orally once daily with or without food. ( 2.2 ) 2.1 Patient Selection Select patients for the first-line treatment of metastatic NSCLC with VIZIMPRO based on the presence of an EGFR exon 19 deletion or exon 21 L858R substitution mutation in tumor specimens. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage The recommended dosage of VIZIMPRO is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs. VIZIMPRO can be taken with or without food [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ] . Take VIZIMPRO the same time each day. If the patient vomits or misses a dose, do not take an additional dose or make up a missed dose but continue with the next scheduled dose. 2.3 Dosage Modifications for Adverse Reactions Reduce the dose of VIZIMPRO for adverse reactions as described in Table 1. Dosage modifications for specific adverse reactions are provided in Table 2. Table 1. VIZIMPRO Recommended Dose Reductions for Adverse Reactions Dose Level Dose (Once Daily) First dose reduction 30 mg Second dose reduction 15 mg Table 2. VIZIMPRO Dosage Modifications for Adverse Reactions Adverse Reaction Severity National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03. Dosage Modification Interstitial lung disease (ILD) [see Warnings and Precautions (5.1) ] Any Grade • Permanently discontinue VIZIMPRO.

• Interstitial Lung Disease (ILD): Permanently discontinue VIZIMPRO if ILD is confirmed. ( 5.1 ) • Diarrhea: Withhold and reduce the dose of VIZIMPRO based on the severity. ( 2.3 , 5.2 ) • Dermatologic Adverse Reactions: Withhold and reduce the dose of VIZIMPRO based on the severity. ( 2.3 , 5.3 ) • Embryo-Fetal Toxicity: VIZIMPRO can cause fetal harm. Advise females of reproductive potential to use effective contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Interstitial Lung Disease (ILD) Severe and fatal ILD/pneumonitis occurred in patients treated with VIZIMPRO and occurred in 0.5% of the 394 VIZIMPRO-treated patients; 0.3% of cases were fatal. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Withhold VIZIMPRO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue VIZIMPRO if ILD is confirmed [see Adverse Reactions (6.1) ] . 5.2 Diarrhea Severe and fatal diarrhea occurred in patients treated with VIZIMPRO. Diarrhea occurred in 86% of the 394 VIZIMPRO-treated patients; Grade 3 or 4 diarrhea was reported in 11% of patients and 0.3% of cases were fatal. Withhold VIZIMPRO for Grade 2 or greater diarrhea until recovery to less than or equal to Grade 1 severity, then resume VIZIMPRO at the same or a reduced dose depending on the severity of diarrhea [see Dosage and Administration (2.3) and Adverse Reactions (6.1) ]. Promptly initiate anti-diarrheal treatment (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhea.

The following adverse drug reactions are described elsewhere in the labeling: • Interstitial Lung Disease [see Warnings and Precautions (5.1) ] • Diarrhea [see Warnings and Precautions (5.2) ] • Dermatologic Adverse Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence >20%) are diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data in the Warnings and Precautions section reflect exposure to VIZIMPRO in 394 patients with first-line or previously treated NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations who received VIZIMPRO at the recommended dose of 45 mg once daily in 4 randomized, active-controlled trials [ARCHER 1050 (N=227), Study A7471009 (N=38), Study A7471011 (N=83), and Study A7471028 (N=16)] and one single-arm trial [Study A7471017 (N=30)]. The median duration of exposure to VIZIMPRO was 10.8 months (range 0.07–68) [see Warnings and Precautions (5) ].

• Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, VIZIMPRO can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on VIZIMPRO use in pregnant women. In animal reproduction studies, oral administration of dacomitinib to pregnant rats during the period of organogenesis resulted in an increased incidence of post-implantation loss and reduced fetal body weight at doses resulting in exposures near the exposure at the 45 mg human dose (see Data) . The absence of EGFR signaling has been shown to result in embryolethality as well as post-natal death in animals (see Data) . Advise pregnant women of the potential risk to a fetus [see Use in Special Populations (8.3) ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Daily oral administration of dacomitinib to pregnant rats during the period of organogenesis resulted in an increased incidence of post-implantation loss, maternal toxicity, and reduced fetal body weight at 5 mg/kg/day (approximately 1.2 times the exposure based on area under the curve [AUC] at the 45 mg human dose).

Metabolism

The maximum dacomitinib plasma concentration (C max ) and AUC at steady state increased proportionally over the dose range of VIZIMPRO 2 mg to 60 mg orally once daily (0.04 to 1.3 times the recommended dose) across dacomitinib studies in patients with cancer. At a dose of 45 mg orally once daily, the geometric mean [coefficient of variation (CV%)] C max was 108 ng/mL (35%) and the AUC 0–24h was 2213 ng∙h/mL (35%) at steady state in a dose-finding clinical study conducted in patients with solid tumors.

• Sep 27, 2018NDANDA211288Pfizer

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Vizimpro, Tablet, 15 mg (NDC 0069-0197-30)To be discontinued
  Sponsor: Pfizer Inc.
  Updated Jun 8, 2026
• Vizimpro, Tablet, 30 mg (NDC 0069-1198-30)To be discontinued
  Sponsor: Pfizer Inc.
  Updated Jun 8, 2026
• Vizimpro, Tablet, 45 mg (NDC 0069-2299-30)To be discontinued
  Sponsor: Pfizer Inc.
  Updated Jun 8, 2026

1. 1Death23732%
2. 2Diarrhoea11916%
3. 3Rash11415%
4. 4Neoplasm Progression7811%
5. 5Paronychia587.8%
6. 6Blood Pressure Increased466.2%
7. 7Malignant Neoplasm Progression425.7%
8. 8Off Label Use354.7%
9. 9Pruritus354.7%
10. 10Dyspnoea314.2%
11. 11Decreased Appetite293.9%
12. 12Vomiting283.8%
13. 13Pain273.6%
14. 14Carcinoembryonic Antigen Increased263.5%
15. 15Drug Interaction263.5%

The 10 most recently updated of 65 ClinicalTrials.gov registrations naming Dacomitinib as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)
  Completed · Observational · 40 enrolled · Pfizer
  NCT04155541updated 2026-06-11
• A Study to Learn About Dacomitinib in Patients With Non-small Cell Lung Cancer.
  Completed · Observational · 29 enrolled · Pfizer
  NCT06321510updated 2026-05-29
• EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study
  Recruiting · Phase 3 · Interventional · 200 enrolled · Region Skane
  NCT06486142updated 2026-05-14
• Korea Post Marketing Surveillance (PMS) Study of Vizimpro
  Completed · Observational · 188 enrolled · Pfizer
  NCT04721106updated 2026-02-10
• Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer
  Completed · Phase 1 · Interventional · 22 enrolled · Memorial Sloan Kettering Cancer Center
  NCT03810807updated 2025-12-23
• Cancer Therapy-Related Cardiac Dysfunction Associated With EGFR-TKIs in Advanced EGFR-mutant Non-small Cell Lung Cancer
  Completed · Observational · 100 enrolled · Taichung Veterans General Hospital
  NCT07267247updated 2025-12-05
• Dacomitinib in Lung Cancer With Uncommon EGFR Mutations
  Active not recruiting · Phase 2 · Interventional · 30 enrolled · Shanghai Chest Hospital
  NCT04504071updated 2025-09-08
• Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC
  Completed · Phase 1 · Phase 2 · Interventional · 35 enrolled · The Netherlands Cancer Institute
  NCT02039336updated 2025-07-08
• Phase 2 Study of Dacomitinib in NSCLC
  Active not recruiting · Phase 2 · Interventional · 118 enrolled · National Cancer Centre, Singapore
  NCT04027647updated 2025-06-12
• Phase-2 Dacomitinib Study on Patients With EGFR-Driven Advanced Solid Tumours With Low EGFR-AS1 IncRNA Expr or Other Novel Emerging Biomarkers
  Active not recruiting · Phase 2 · Interventional · 24 enrolled · National Cancer Centre, Singapore
  NCT04946968updated 2025-06-11

Frequently asked questions

How does Dacomitinib work?

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.

What is Dacomitinib used for?

According to FDA labeling, Dacomitinib carries indications including: VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dacomitinib?

Dacomitinib is classified as Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors, Protein Kinase Inhibitors, Increased Cellular Death.

What are the brand names for Dacomitinib?

Dacomitinib is marketed under brand names including Vizimpro.

What are the contraindications for Dacomitinib?

Dacomitinib labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.