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Osimertinib

(Tagrisso®)

Tagrisso®

Drug updated on 3/28/2024

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.
  • 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.
  • 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.

Summary
This AI-generated content is provided without warranty and may be inaccurate or outdated; it should be used only as a research starting point, with no liability accepted for reliance on it. Learn more.

  • Osimertinib (Tagrisso) is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor mutations, and for the first line treatment of metastatic NSCLC.
  • A total of 26 systematic reviews/meta-analyses were reviewed to gather information about this drug's safety and effectiveness.
  • Compared to other EGFR tyrosine kinase inhibitors such as afatinib, erlotinib, gefitinib, osimertinib demonstrated superior progression-free survival benefits across various settings including in patients with T790M mutations which are resistant to earlier generation TKIs.
  • The data suggest that osimertinib is effective both as a first-line treatment and in cases where tumors have developed resistance to initial TKI therapies; it has been particularly noted for its effectiveness in NSCLC patients with brain metastases providing significant PFS benefit even when accounting for T790M status.
  • For older patients harboring the EGFR mutation, osimertinib at a dose of 80 mg/day was recommended showing that it is feasible regardless of age due to mild manageable side effects critical in geriatric oncology care.
  • In terms of specific population types like those harboring EGFR-positive mutations with brain metastases or different subtypes like exon 19 deletions vs exon 21 L858R mutations - osimertinb significantly increases PFS compared acting as an important treatment option controlling CNS involvement while displaying varied advantages based on presence specific mutation subtype respectively.
  • Studies focusing on Asian populations suggested comparable benefits from using Osimertnimb (Tagrisso), although direct comparisons between ethnic subgroups were limited.
  • Adverse events associated with use include diarrhea paronychia rash dry skin stomatitis but they're generally manageable less severe than those associated with chemotherapy or combination therapy regimens.

Product Monograph / Prescribing Information

Document TitleYearSource
Tagrisso (osimertinib) Prescribing Information.2022AstraZeneca Pharmaceutica, Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Clinical Outcomes of Afatinib Versus Osimertinib in Patients With Non-Small Cell Lung Cancer With Uncommon EGFR Mutations: A Pooled Analysis2023The oncologist
Clinical and Pharmacoeconomic combined report: osimertinib (Tagrisso) for adjuvant therapy after tumour resection in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. 2022CADTH
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
Overall survival benefits of first-line treatments for Asian patients with advanced EGFR-mutated NSCLC harboring L858R mutation: a systematic review and network meta-analysis.2022JTO Clinical and Research Reports
Non-small cell lung cancer with EGFR exon 20 insertion mutation: a systematic literature review and meta-analysis of patient outcomes. 2022Current Medical Research and Opinion
Comparison of the efficacy and safety of first-line treatments based on clinicopathological characteristics for patients with advanced epidermal growth factor receptor mutated non-small-cell lung cancer: A systematic review and network meta-analysis.2022Critical Reviews in Oncology/Hematology
Uncommon EGFR Compound Mutations in Non-Small Cell Lung Cancer (NSCLC): A Systematic Review of Available Evidence2022Current oncology
Insensitivity to T790M mutation? A pooled analysis of outcomes following osimertinib for the treatment of NSCLC patients harboring uncommon epidermal growth factor receptor mutation2022Frontiers in pharmacology
Cost-effectiveness of osimertinib in the treatment of advanced EGFR-mutated non-small cell lung cancer: a systematic review2022Expert review of pharmacoeconomics & outcomes research
Overall Survival Benefits of First-Line Treatments for Asian Patients With Advanced EGFR-Mutated NSCLC Harboring L858R Mutation: A Systematic Review and Network Meta-Analysis 2022JTO clinical and research reports
Efficacy of Osimertinib in EGFR-Mutated Advanced Non-small-Cell Lung Cancer With Different T790M Status Following Resistance to Prior EGFR-TKIs: A Systematic Review and Meta-analysis2022Frontiers in oncology
Assessment report: Tagrisso. 2021EMA
The efficacy and safety of osimertinib in advanced non-small cell lung cancer patients with Thr790Met resistance mutations: a systematic review and meta-analysis.2021Annals of Palliative Medicine
Toxicity profile of epidermal growth factor receptor tyrosine kinase inhibitors for patients with lung cancer: a systematic review and network meta-analysis.2021Critical Reviews in Oncology/ Hematology
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-analysis.2021Lung Cancer
The dawn of a new era, adjuvant EGFR inhibition in resected non-small cell lung cancer2021Therapeutic advances in medical oncology
Patterns and Treatment Strategies of Osimertinib Resistance in T790M-Positive Non-Small Cell Lung Cancer: A Pooled Analysis2021Frontiers in oncology
The efficacy and safety of Osimertinib in advanced non-small cell lung cancer patients with Thr790Met resistance mutations: a systematic review and meta-analysis2021Annals of palliative medicine
Resistance mechanisms of epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer patients: A meta-analysis2021Thoracic cancer
Adjuvant EGFR-TKIs for Patients With Resected EGFR-Mutant Non-Small Cell Lung Cancer: A Meta-Analysis of 1,283 Patients2021Frontiers in oncology
Cell-Free Circulating Tumour DNA Blood Testing to Detect EGFR T790M Mutation in People With Advanced Non-Small Cell Lung Cancer: A Health Technology Assessment2020Ontario health technology assessment series
Assessment of effectiveness and safety of osimertinib for patients with intracranial metastatic disease: a systematic review and meta-analysis.2020JAMA Network Open
Efficacy of osimertinib for the treatment of previously EGFR TKI treated NSCLC patients: a meta-analysis2020Clinical & translational oncology
Osimertinib for EGFR-mutant lung cancer with central nervous system metastases: a meta-analysis and systematic review2020Annals of palliative medicine
The Status of the EGFR T790M Mutation is associated with the Clinical Benefits of Osimertinib Treatment in Non-small Cell Lung Cancer Patients: A Meta-Analysis2020Journal of Cancer
Metastatic non-small cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. 2019Annals of Oncology
Final clinical guidance report: osimertinib (Tagrisso) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.2019CADTH
Efficacy and safety of osimertinib in treating EGFR-mutated advanced NSCLC: A meta-analysis2019International journal of cancer
Osimertinib or EGFR-TKIs/chemotherapy in patients with EGFR-mutated advanced nonsmall cell lung cancer: A meta-analysis2019Medicine
Adjusted Indirect Comparison Using Propensity Score Matching of Osimertinib to Platinum-Based Doublet Chemotherapy in Patients with EGFRm T790M NSCLC Who Have Progressed after EGFR-TKI2018Clinical drug investigation
Curative effectiveness and safety of osimertinib in the treatment for non-small-cell lung cancer: a meta-analysis of the experimental evidence2018OncoTargets and therapy

Clinical Practice Guidelines

Document TitleYearSource
Therapy for stage IV non–small-cell lung cancer with driver alterations: ASCO and OH (CCO) joint guideline update.2021Journal of Clinical Oncology