Drug updated on 9/4/2024
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
- Tagrisso (osimertinib) is 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; in combination with pemetrexed and platinum-based chemotherapy, for 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; and for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.
- This summary is based on the review of 23 systematic review(s)/meta-analysis(es). [1-23]
- Progression-Free Survival (PFS): Adding bevacizumab to osimertinib did not significantly prolong PFS (HR = 1.00, 95% CI: 0.78-1.27). Osimertinib was superior to other first, second, and third-generation TKIs and chemotherapy regimens (HRs: 0.09-0.61). Afatinib provided a more profound and durable PFS benefit compared to osimertinib in patients with uncommon EGFR mutations (11.0 vs. 7.0 months, P=0.044).
- Overall Survival (OS): The combination of osimertinib and bevacizumab did not significantly improve OS (HR = 1.01, 95% CI: 0.73-1.41). Osimertinib demonstrated superior OS benefits for patients with T790M mutations compared to other EGFR-TKIs (HR = 0.66).
- Objective Response Rate (ORR): Afatinib had a slightly higher ORR compared to osimertinib (60.6% vs. 50.3%). The addition of bevacizumab to osimertinib did not improve ORR (risk ratio = 1.12, 95% CI: 0.90-1.38).
- Disease Control Rate (DCR): Osimertinib showed a pooled DCR of 93% (95% CI 88% to 97%) in patients with leptomeningeal metastases.
- Adverse Events (AEs): Increased incidence of nausea, oral mucositis, hypertension, and proteinuria were observed with osimertinib combined with bevacizumab. Common AEs for osimertinib alone included rash (53%), diarrhea (45%), paronychia (35%), decreased appetite (35%), and dry skin (27%).
- Severe Adverse Events (SAEs): Osimertinib had a lower incidence of severe AEs compared to other treatments, with a pooled incidence of serious AEs reported as less than 2%. Combination treatments, particularly erlotinib plus bevacizumab, were associated with higher overall toxicity.
- Subgroup Considerations: Osimertinib was ranked highly in avoiding severe AEs in Asian populations and demonstrated an acceptable safety profile in patients with brain metastases.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tagrisso (osimertinib) Prescribing Information. | 2024 | AstraZeneca Pharmaceuticals LP., Wilmington, DE |