Drug updated on 9/4/2024
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
- Vizimpro (dacomitinib) 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.
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Progression-Free Survival (PFS): Dacomitinib demonstrated promising efficacy in patients with major uncommon EGFR mutations (G719X, S768I, L861Q), specific subtypes of EGFR exon 20 insertion mutations, and HER2 exon 20 insertion mutation, showing superior PFS in Asian patients with EGFR-mutated NSCLC compared to standards of care (HR = 0.62). However, it ranked lower than osimertinib and certain combination therapies for PFS in patients with or without brain metastases.
- Overall Survival (OS): Dacomitinib ranked among the top four treatment strategies for OS in first-line settings with a SUCRA score of 0.79 but did not show significant OS benefits in Asian patients with the EGFR 19del mutation when compared to other treatments like bevacizumab plus chemotherapy and osimertinib.
- Disease Control Rate (DCR) and Objective Response Rate (ORR): While specific DCR and ORR data for dacomitinib were not detailed, it demonstrated good disease control for uncommon EGFR mutations. Comparatively, erlotinib plus bevacizumab and erlotinib plus ramucirumab showed superior ORR.
- Specific adverse events or safety concerns for dacomitinib were not detailed, but it showed fewer grade ≥3 adverse events compared to combination therapies such as erlotinib plus bevacizumab and gefitinib plus pemetrexed-based chemotherapy.
- Osimertinib ranked highest for avoiding severe adverse events, with fewer grade ≥3 adverse events compared to other drugs, including dacomitinib. Combination therapies generally caused the most grade ≥3 adverse events, indicating higher toxicity, especially in Asian patients with EGFR 19del mutation.
- There is a potential benefit of combining dacomitinib with olaparib in patients with osimertinib-resistant brain and leptomeningeal metastases.
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 |
The Japanese Lung Cancer Society guideline for non-small cell lung cancer, stage IV. | 2019 | International Journal of Clinical Oncology |