Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration granted approval to osimertinib for the adjuvant treatment after tumor resection of 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.
This is written in the approval document as:
TAGRISSO is a kinase inhibitor indicated for 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.
Citation
AstraZeneca Pharmaceuticals, LP. Tagrisso (osimertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s033lbl.pdf. Revised September 2024. Accessed October 30, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | EGFR Exon 19 (Deletion) | Non-Small Cell Lung Cancer | Osimertinib | |
| Sensitivity (+) | EGFR p.L858R | Non-Small Cell Lung Cancer | Osimertinib | |
| Sensitivity (+) | EGFR p.L858R | Non-Small Cell Lung Cancer | Osimertinib | |
| Sensitivity (+) | EGFR Exon 19 (Deletion) | Non-Small Cell Lung Cancer | Osimertinib | |
| Sensitivity (+) | EGFR Exon 19 (Deletion) | Non-Small Cell Lung Cancer | Osimertinib | |
| Sensitivity (+) | EGFR p.L858R | Non-Small Cell Lung Cancer | Osimertinib |