Osimertinib

(Tagrisso®)

Osimertinib

Drug updated on 12/11/2024

Dosage FormTablet (oral; 40 mg, 80 mg)
Drug ClassKinase 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

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Summary
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  • 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 epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs), particularly in patients previously treated with EGFR-TKIs.
  • 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 TitleYearSource
Tagrisso (osimertinib) Prescribing Information.2024AstraZeneca, Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
First-line concomitant EGFR-TKI + chemotherapy versus EGFR-TKI alone for advanced EGFR-mutated NSCLC: a meta-analysis of randomized phase III trials2024Expert Review of Anticancer Therapy
Osimertinib is associated with improved outcomes in pre-treated non-small cell lung cancer leptomeningeal metastases: A systematic review and meta-analysiss2024Heliyon
Comparison of osimertinib plus bevacizumab against osimertinib alone in NSCLC harboring EGFR mutations: a systematic review and meta-analysis2024Therapeutic Advances in Medical Oncology
Efficacy and safety of osimertinib for leptomeningeal metastases from EGFR-mutant non-small cell lung cancer: a pooled analysis2023European Journal of Medical Research
Rational application of EGFR-TKI adjuvant therapy in patients with completely resected stage IB-IIIA EGFR-mutant NSCLC: a systematic review and meta-analysis of 11 randomized controlled trials2023BMC Cancer
Comparison of the efficacy and safety of first-line treatments for of advanced EGFR mutation-positive non-small-cell lung cancer in Asian populations: a systematic review and network meta-analysis2023Frontiers in Pharmacology
Osimertinib in the Treatment of EGFR Mutation-Positive Advanced Non-Small Cell Lung Cancer: A Meta-Analysis2023Pharmacology
An updated network meta-analysis of EGFR-TKIs and combination therapy in the first-line treatment of advanced EGFR mutation positive non-small cell lung cancer2022Frontiers in Oncology
Overall Survival Benefits of First-Line Treatments for Asian Patients with Advanced Epidermal Growth Factor Receptor-Mutated NSCLC Harboring Exon 19 Deletion: A Systematic Review and Network Meta-Analysis2022Cancers
Overall Survival Benefits of First-Line Treatments for Asian Patients With Advanced EGFR-Mutated NSCLC Harboring L858R Mutation: A Systematic Review and Network Meta-Analysis2022JTO Clinical and Research Reports
Olaparib Combined With Dacomitinib in Osimertinib-Resistant Brain and Leptomeningeal Metastases From Non-Small Cell Lung Cancer: A Case Report and Systematic Review2022Frontiers in Oncology
Efficacy and safety of adjuvant EGFR-TKIs for resected non-small cell lung cancer: a systematic review and meta-analysis based on randomized control trials2022BMC Cancer
MET-Targeted Therapies and Clinical Outcomes: A Systematic Literature Review2022Molecular Diagnosis & therapy
Targeted Therapy for Older Patients with Non-Small Cell Lung Cancer: Systematic Review and Guidelines from the French Society of Geriatric Oncology (SoFOG) and the French-Language Society of Pulmonology (SPLF)/French-Language Oncology Group (GOLF)2022Cancers
Use of tyrosine kinase inhibitors during pregnancy for oncogenic-driven advanced non-small cell lung carcinoma2021Lung Cancer (Amsterdam, Netherlands)
Efficacy and safety of treatment modalities across EGFR selected/unselected populations with non-small cell lung cancer and brain metastases: A systematic review and Bayesian network meta-analysis2021Lung Cancer (Amsterdam, Netherlands)
Toxicity profile of epidermal growth factor receptor tyrosine kinase inhibitors for patients with lung cancer: A systematic review and network meta-analysis2021Critical Reviews in Oncology/Hematology
Osimertinib for EGFR-mutant lung cancer with central nervous system metastases: a meta-analysis and systematic review2020Annals of Palliative Medicine
The efficacy and safety of osimertinib in treating nonsmall cell lung cancer: A PRISMA-compliant systematic review and meta-analysis2020Medicine
Efficacy and safety of therapies for EGFR-mutant non-small cell lung cancer with brain metastasis: an evidence-based Bayesian network pooled study of multivariable survival analyses2020Aging

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