Drug updated on 10/31/2024
| Dosage Form | Tablet (oral; 40 mg, 80 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
- Indicated for the first line treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
- Indicated in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
- Indicated for the treatment of patients with metastatic EFGR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.
Latest News
Summary
- This summary is based on the review of 20 systematic review(s)/meta-analysis(es). [1-20]
- Osimertinib significantly improved progression-free survival (PFS) in patients with brain metastases (Hazard Ratio (HR): 0.41) and those with leptomeningeal metastasis (LM), demonstrating superior PFS and overall survival (OS) compared to other EGFR-TKIs, particularly in patients previously treated with EGFR (epidermal growth-factor - receptor)-TKIs (tyrosine kinase inhibitors).
- The combination of osimertinib and bevacizumab resulted in a notable PFS benefit specifically in smokers, highlighting the drug's efficacy in this subgroup, while osimertinib alone was effective and safe across various populations, including the Asian population, which showed fewer serious adverse events and high PFS rankings.
- Osimertinib is associated with common adverse events (AEs) including rash, diarrhea, paronychia, decreased appetite, and dry skin, indicating a generally manageable safety profile, particularly in patients with brain metastases where efficacy is also noted.
- In combination with bevacizumab, osimertinib showed an increased incidence of AEs such as nausea, oral mucositis, hypertension, and proteinuria compared to osimertinib alone, highlighting the potential for higher toxicity in smokers benefiting from this combination therapy.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Tagrisso (osimertinib) Prescribing Information. | 2024 | AstraZeneca, Wilmington, DE |