Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) EGFR Exon 19 (Deletion) Non-Small Cell Lung Cancer Osimertinib
FDA (1) EGFR p.L858R Non-Small Cell Lung Cancer Osimertinib