NDAORALTABLETPriority Review
Approved
Nov 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
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 intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TAGRISSO (osimertinib) is an oral kinase inhibitor that targets EGFR mutations in non-small cell lung cancer (NSCLC). It is a third-generation tyrosine kinase inhibitor designed to overcome resistance mechanisms in EGFR-mutant tumors.
$1.2BPart D
PeakStable
16.2 years to LOETAGRISSO remains at peak commercial performance with strong claims volume; the established brand supports stable field and commercial operations at AstraZeneca.
Mechanism 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 (20)
Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)
Started Sep 2026
850 enrolled
Non-Small Cell Lung Cancer
A Phase 2 Study of ABSK043 Combined With Osimertinib
Started Aug 2026
72 enrolled
Non-Small Cell Lung Cancer With EGFR-mutated and PD-L1 Positive
A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)
Started Aug 2026
418 enrolled
Non-small Cell Lung Cancer Stage III
Barriers and Facilitators of Persistence With Adjuvant Osimertinib
Started Aug 2026
100 enrolled
Non-small Cell Lung Cancer
Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
Started Aug 2026
16 enrolled
Small Cell Lung Cancer ( SCLC )Transformed 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.