Regulatory approval

Published by the Food and Drug Administration. Approved

TAGRISSO is a kinase inhibitor 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 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.

Therapeutic response

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

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