Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 15 mg, 30 mg, 45 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
Latest News
Summary
- This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
- Dacomitinib demonstrated improved progression-free survival (PFS) in older adult patients with advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), with a hazard ratio of 0.654 (95% confidence interval (CI): 0.474 to 0.903; p = 0.01), and showed good disease control in patients with major uncommon EGFR mutations.
- Osimertinib frequently ranked higher than dacomitinib for PFS and was comparable or superior in overall survival (OS) outcomes, indicating its efficacy across multiple studies.
- In patients with central nervous system (CNS) metastases, dacomitinib exhibited effective intracranial tumor control, regardless of mutation status, suggesting its potential utility in this subgroup.
- Dacomitinib also showed notable efficacy in older adults (>65 years) and patients with type 2 diabetes mellitus (T2DM), with benefits in both PFS and OS, particularly in NSCLC patients with T2DM.
- Dacomitinib was associated with greater overall toxicity compared to icotinib, showing higher incidences of grade ≥3 adverse events, indicating a significant safety concern in its use.
- Gefitinib and erlotinib presented a higher risk for hepatotoxicity, with gefitinib showing a relative risk for alanine aminotransferase (ALT) elevation of 2.60 (95% CI: 1.30-5.20) compared to dacomitinib, highlighting different toxicity profiles among EGFR tyrosine kinase inhibitors (TKIs).
- Osimertinib generally exhibited a safer profile with fewer grade ≥3 adverse events than dacomitinib, while combination therapies such as erlotinib plus bevacizumab and gefitinib plus pemetrexed-based chemotherapy had the highest incidences of severe adverse events, raising concerns regarding their safety in clinical use.
- Dacomitinib demonstrated improved progression-free survival (PFS) in older adults (>65 years) with advanced EGFR-mutated NSCLC, with a hazard ratio of 0.654 (95% CI: 0.474 to 0.903; p = 0.01), and showed promising efficacy in patients with major uncommon EGFR mutations. Additionally, while no significant OS benefits were observed in Asian populations, dacomitinib ranked highly for PFS in some studies. Furthermore, patients with T2DM experienced greater benefits from MET-EGFR-TKIs, including dacomitinib, particularly in NSCLC.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Vizimpro (dacomitinib) Prescribing Information. | 2020 | Pfizer Inc., New York, NY |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Non–small cell lung cancer, version 3.2022, NCCN clinical practice guidelines in oncology. | 2022 | Journal of the National Comprehensive Cancer Network |
| Therapy for stage IV non–small-cell lung cancer with driver alterations: ASCO and OH (CCO) joint guideline update. | 2021 | Journal of Clinical Oncology |
| Metastatic non-small cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. | 2020 | European Society for Medical Oncology |