Osimertinib

(Tagrisso®)

Osimertinib

Drug updated on 5/17/2024

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.

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This AI-generated content is provided without warranty and may be inaccurate or outdated; it should be used only as a research starting point, with no liability accepted for reliance on it.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 for adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC), first-line treatment of metastatic NSCLC, and combination therapy with pemetrexed and platinum-based chemotherapy. It has shown superiority or comparable efficacy to other therapeutic agents in terms of progression-free survival (PFS) and overall survival.
  • A review was conducted on 25 systematic reviews/meta-analyses regarding the use of osimertinib in treating NSCLC with different epidermal growth factor receptor mutations.
  • The medication demonstrated remarkable efficacy specifically in patients with T790M mutation-positive NSCLC by significantly improving PFS and overall survival, especially among treatment-na├»ve patients.
  • Osimertinib showed considerable effectiveness against brain and leptomeningeal metastases due to its CNS penetration capability. This makes it a viable option for managing these types of complications associated with advanced stages of NSCLC.
  • In cases where uncommon EGFR mutations were present, osimertinib exhibited favorable clinical activities. However, afatinib compared to osimertinib showed more profound benefits particularly among those harboring such rare mutations.
  • Safety profile analysis revealed that common adverse events include diarrhea, rash, paronychia, decreased appetite, and dry skin but are generally manageable. Compared to some combination therapies, the incidence rate for severe adverse events was lower when using this medication alone.
  • Certain patient characteristics like age, smoking status, and presence of brain metastases might influence the safety profile as well as the effectiveness of osimertinib. For instance, it provided superior PFS benefit within Asian populations under certain regimens.
  • Studies have highlighted that TKIs including osimertinib as monotherapy or in combination can prolong survival and provide better control with lower risk of adverse events compared to basic chemotherapy among Asian populations.

Product Monograph / Prescribing Information

Document TitleYearSource
Tagrisso (osimertinib) Prescribing Information.2024AstraZeneca Pharmaceuticals LP., Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparison of osimertinib plus bevacizumab against osimertinib alone in NSCLC harboring EGFR mutations: a systematic review and meta-analysis.2024Therapeutic Advances in Medical Oncology
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-analysis.2023Frontiers in Pharmacology
Clinical outcomes of afatinib versus osimertinib in patients with non-small cell lung cancer with uncommon EGFR mutations: a pooled analysis.2023The Oncologist
Efficacy and safety of osimertinib for leptomeningeal metastases from EGFR-mutant non-small cell lung cancer: a pooled analysis.2023European Journal of Medical Research
MET-targeted therapies and clinical outcomes: a systematic literature review.2022Molecular Diagnosis and Therapy
Olaparib combined with dacomitinib in osimertinib-resistant brain and leptomeningeal metastases from non-small cell lung cancer: a case report and systematic review.2022Frontiers in Oncology
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
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 and safety of osimertinib for patients with EGFR-mutated NSCLC: a systematic review and meta-analysis of randomized controlled studies.2022Acta Oncologica
Insensitivity to T790M mutation? A pooled analysis of outcomes following osimertinib for the treatment of NSCLC patients harboring uncommon epidermal growth factor receptor mutation.2022Frontiers in Pharmacology
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
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
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 cancer.2021Therapeutic Advances in Medical Oncology
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
Resistance mechanisms of epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer patients: a meta-analysis.2021Thoracic Cancer
Adjuvant EGFR-TKIs for patients with resected EGFR-mutant non-small cell lung cancer: a meta-analysis of 1,283 patients.2021Frontiers in Oncology
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 analyses.2020Aging
Efficacy of osimertinib for the treatment of previously EGFR TKI treated NSCLC patients: a meta-analysis.2020Clinical & Translational Oncology
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-analysis.2020Medicine (Baltimore)
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-analysis.2020Journal of Cancer
Metastatic non-small cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up.2019Annals of Oncology
Efficacy and safety of first-line treatments for patients with advanced epidermal growth factor receptor mutated, non-small cell lung cancer: systematic review and network meta-analysis.2019British Medical Journal
Efficacy and safety of osimertinib in treating EGFR-mutated advanced NSCLC: a meta-analysis.2019International Journal of Cancer
Osimertinib or EGFR-TKIs/chemotherapy in patients with EGFR-mutated advanced nonsmall cell lung cancer: a meta-analysis.2019Medicine

Clinical Practice Guidelines