TAGRISSO (osimertinib mesylate) · AstraZeneca
Tagrisso is a kinase inhibitor indicated for the treatment of adult patients with non-small cell lung cancer (NSCLC) harboring specific epidermal growth factor receptor (EGFR) mutations. It is utilized across various disease stages, including as adjuvant therapy following tumor resection, for locally advanced unresectable disease after chemoradiation, and as a first-line treatment for metastatic cases. Additionally, it is indicated for patients with metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed during or after prior EGFR tyrosine kinase inhibitor therapy.
How TAGRISSO Works
Osimertinib is a kinase inhibitor that binds irreversibly to mutant forms of the epidermal growth factor receptor (EGFR), such as exon 19 deletions and L858R mutations. By targeting these mutations at lower concentrations than wild-type EGFR, the drug inhibits the signaling pathways that drive tumor growth. The medication and its active metabolites also inhibit other kinases, including HER2 and HER4, and have demonstrated the ability to distribute to the brain in animal models.
What is Tagrisso?
Tagrisso (osimertinib mesylate) is sold under an FDA application first approved in November 2015, held by AstraZeneca.
How much does Tagrisso sell?
AstraZeneca reported $7.8 billion of Tagrisso sales in the four quarters from Q4 2025 to Q3 2026, $2.1 billion of it in Q3 2026. Source: AstraZeneca's Q3 2026 report.
From FDA's approval records, the company's own quarterly report (linked above where shown) and TheraRadar's curated drug targets.
Details
- Status
- Prescription
- First Approved
- 2015-11-13
- Patent Cliff
- 2042
- Revenue
- $2.1B (Q3-2026)
- Routes
- ORAL
- Dosage Forms
- TABLET
Latest TAGRISSO News
All TAGRISSO news →- Tagrisso plus Orpathys reduced the risk of disease progression or death by 45% and the risk of death by 32% in MET-driven EGFR-mutated lung cancer after progression on Tagrisso ↗
- AstraZeneca to present overall survival data from four pivotal Phase III trials in Presidential Symposia at ESMO 2026 featuring Sone-Ve, Imfinzi, Tagrisso and Orpathys ↗
- Tagrisso demonstrated unprecedented eight-year landmark survival in early-stage EGFR-mutated lung cancer in ADAURA Phase III trial ↗
- Tagrisso plus Orpathys demonstrated statistically significant and highly clinically meaningful improvement in progression-free survival in 1st-line MET-overexpressing EGFR-mutated lung cancer ↗
TAGRISSO Approval History
What TAGRISSO Treats
5 indicationsTAGRISSO is approved for 5 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adjuvant therapy after tumor resection in adult patients with EGFR exon 19 deletions or exon 21 L858R mutation-positive non-small cell lung cancer (NSCLC)
- Locally advanced, unresectable (stage III) EGFR exon 19 deletions or exon 21 L858R mutation-positive NSCLC that has not progressed during or following platinum-based chemoradiation therapy
- First-line treatment of adult patients with metastatic EGFR exon 19 deletions or exon 21 L858R mutation-positive NSCLC
- First-line treatment of adult patients with locally advanced or metastatic EGFR exon 19 deletions or exon 21 L858R mutation-positive NSCLC, in combination with pemetrexed and platinum-based chemotherapy
- Metastatic EGFR T790M mutation-positive NSCLC in patients whose disease has progressed on or after EGFR tyrosine kinase inhibitor therapy
TAGRISSO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TAGRISSO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TAGRISSO treats. First-in-class if their pivotal trials read out positive.
AstraZeneca's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06525246 | ONO-7475-03 jRCT2051210045 | Ph 1 | completed | Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer |
| NCT07229729 | SHR-A2102-212 | Ph 2 | recruiting | A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer |
| NCT06829459 | SYH2065-002 | Ph 3 | recruiting | A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients After Resistance to EGFR-TKIs |
| NCT06530719 | IRB-2024-701 | Ph 2 | not yet recruiting | A Study to Evaluate the Efficacy of Osimertinib in Patients With EGFR-sensitive Mutated Non-small Cell Lung Cancer Progression After Receiving Adjuvant Targeted Therapy Following Radical Surgery |
| NCT06306456 | GH21C201 | Ph 1, Ph 2 | recruiting | A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TAGRISSO FDA Label Details
Indications & Usage
FDA Label (PDF)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. • 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. ...
TAGRISSO Patents & Exclusivity
Patents (5 active)
Exclusivity
Pro Intelligence Preview
Deep insights for TAGRISSO
Revenue Insights
- • Q3-2026: $2.1B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 68 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.