TAGRISSO
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.
Details
- Status
- Prescription
- First Approved
- 2015-11-13
- Routes
- ORAL
- Dosage Forms
- TABLET
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 Target & Pathway
ProTarget
A receptor tyrosine kinase that promotes cell growth and division. Approximately 20% of breast cancers overexpress HER2, leading to aggressive tumor growth. Targeting HER2 blocks these growth signals and can trigger immune-mediated destruction of cancer cells.
Pathway Context
HER2 forms dimers with other HER family members to activate growth signaling
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
TAGRISSO Competitors
Pro10 other drugs also target HER2. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (HER2). Earlier expiry dates signal biosimilar/generic opportunities.
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
ProIndications & 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 (68 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.