Tagrisso (osimertinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	6
TAGRISSO is a kinase inhibitor indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
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.	4
TAGRISSO is a kinase inhibitor indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.	1
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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	EGFR Exon 19 (Deletion)	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
Sensitivity (+)	EGFR p.L858R	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	Cisplatin, Osimertinib, Pemetrexed
Sensitivity (+)	EGFR p.L858R	Non-Small Cell Lung Cancer	Carboplatin, Osimertinib, Pemetrexed
Sensitivity (+)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Carboplatin, Osimertinib, Pemetrexed
Sensitivity (+)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Cisplatin, Osimertinib, Pemetrexed
Sensitivity (+)	EGFR p.T790M	Non-Small Cell Lung Cancer	Osimertinib