FDA label
What is Tagrisso used for?
Tagrisso contains osimertinib. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Tagrisso lists 5 uses: Adjuvant Treatment of EGFR Mutation-Positive Non-Small Cell Lung Cancer (NSCLC); Locally Advanced, Unresectable (Stage III) EGFR Mutation-Positive NSCLC; First-line Treatment of EGFR Mutation-Positive Metastatic NSCLC; First-line Treatment of EGFR Mutation-Positive Locally Advanced or Metastatic NSCLC; and 1 more.
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Tagrisso, tablet, film coated
Indications and Usage, quoted from the label by AstraZeneca Pharmaceuticals LP (NDA208065). Cross-references to other label sections are left out.
Adjuvant Treatment of EGFR Mutation-Positive Non-Small Cell Lung Cancer (NSCLC)
TAGRISSO is indicated as 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.
Locally Advanced, Unresectable (Stage III) EGFR Mutation-Positive NSCLC
TAGRISSO is 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.
First-line Treatment of EGFR Mutation-Positive Metastatic NSCLC
TAGRISSO is 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.
First-line Treatment of EGFR Mutation-Positive Locally Advanced or Metastatic NSCLC
TAGRISSO in combination with pemetrexed and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
Previously Treated EGFR T790M Mutation-Positive Metastatic NSCLC
TAGRISSO is 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 tyrosine kinase inhibitor (TKI) therapy.
Source: DailyMed label, set id 5e81b4a7-b971-45e1-9c31-29cea8c87ce7, version 37, effective September 14, 2026. NDC 0310-1248, one of 4 listings for this product.
Questions
What is Tagrisso used for?
The FDA label for Tagrisso lists 5 uses: Adjuvant Treatment of EGFR Mutation-Positive Non-Small Cell Lung Cancer (NSCLC); Locally Advanced, Unresectable (Stage III) EGFR Mutation-Positive NSCLC; First-line Treatment of EGFR Mutation-Positive Metastatic NSCLC; First-line Treatment of EGFR Mutation-Positive Locally Advanced or Metastatic NSCLC; and 1 more.
What drug class is Tagrisso?
FDA lists osimertinib in the Kinase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.