Drug updated on 7/25/2024
| 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
- Osimertinib (Tagrisso) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor primarily indicated for non-small cell lung cancer (NSCLC) with specific EGFR mutations.
- The information was derived from 23 systematic reviews and meta-analyses documents.
- In comparison to osimertinib monotherapy, adding bevacizumab did not show an increase in progression-free survival, overall survival, or objective response rate but increased adverse events like nausea and hypertension. Smokers showed significant prolongation of PFS with the combination therapy.
- Among various first-line treatments, osimertinib ranked high in terms of safety but had a lower overall survival ranking compared to some combinations such as gefitinib plus chemotherapy. Erlotinib-based combinations showed better PFS but higher risks of adverse events.
- Afatinib demonstrated slightly better progression-free survival than osimertinib when treating uncommon EGFR mutations; however, both drugs had similar objective response rates.
- For patients with leptomeningeal metastases in EGFR-mutant NSCLC, osimertinib exhibited substantial efficacy with a high disease control rate and manageable safety profile.
- Combining MET inhibitors like savolitinib with osimertinib has shown potential for overcoming resistance in EGFR-mutant NSCLC cases that have progressed on prior therapies.
- Subgroup analyses reveal that while osimertinib provides substantial benefits for patients with certain mutation types such as exon 19 deletions, it may not be as effective against other mutation types compared to some drug combinations.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Tagrisso (osimertinib) Prescribing Information. | 2024 | AstraZeneca Pharmaceuticals LP., Wilmington, DE |