NDAORALTABLETPriority Review
Approved
Nov 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
42
Data completeness
5/8 — Partial
Priority Review
TAGRISSO (osimertinib) by AstraZeneca is kinase inhibitors [moa]. First approved in 2015.
Drug data last refreshed 1h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TAGRISSO (osimertinib) is an oral kinase inhibitor developed by AstraZeneca and approved by the FDA on November 13, 2015. It is indicated for treating non-small cell lung cancer (NSCLC) patients with specific EGFR mutations. The drug works by selectively inhibiting epidermal growth factor receptor (EGFR) tyrosine kinase, blocking cancer cell proliferation. TAGRISSO has become a cornerstone therapy in precision oncology for EGFR-mutant lung cancer, serving as both a first-line and subsequent therapy option.
$1.2BPart D
16.6 years to LOEMechanism of Action
Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (42)
Barriers and Facilitators of Persistence With Adjuvant Osimertinib
Started Jun 2026
100 enrolled
Non-small Cell Lung Cancer
Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC.
Started May 2026
100 enrolled
Non-small Cell Lung Cancer
Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
Started May 2026
16 enrolled
Small Cell Lung Cancer ( SCLC )Transformed Small Cell Lung Cancer
Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study
Started Apr 2026
60 enrolled
Lung Cancer
Boosting Osimertinib Blood Brain Barrier Penetration
Started Apr 2026
7 enrolled
Non-Small Cell Lung Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.