Regulatory approval

Published by the Food and Drug Administration. Approved

TAGRISSO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have 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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Osimertinib
FDA (2)	EGFR p.L858R	Non-Small Cell Lung Cancer	Osimertinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2024-09-25	Food and Drug Administration	Indication received traditional approval.