NDAORALTABLETPriority Review
Approved
May 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
IRESSA (gefitinib) by AstraZeneca is protein kinase inhibitors [moa]. First approved in 2003.
Drug data last refreshed 8h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IRESSA (gefitinib) is an oral small-molecule protein kinase inhibitor approved in 2003 for treating non-small-cell lung cancer (NSCLC). It works by selectively inhibiting epidermal growth factor receptor (EGFR) tyrosine kinase, blocking cancer cell proliferation. Gefitinib is particularly effective in patients with EGFR-sensitizing mutations.
$0.004BPart D
LOE ApproachingDeclining
Product is in late-stage lifecycle with modest Part D utilization; career roles likely focused on managed decline and transition planning rather than growth.
Mechanism of Action
Protein Kinase Inhibitors
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC
Started Jul 2019
337 enrolled
Locally Advanced or Metastatic NSCLC
DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
Started Sep 2018
20 enrolled
Non Small Cell Lung Cancer
Phase III Study of Nazartinib (EGF816) Versus Erlotinib/Gefitinib in First-line Locally Advanced / Metastatic NSCLC With EGFR Activating Mutations
Started Jul 2018
0Carcinoma, Non-small Cell Lung
Gefitinib Combine Radiotherapy as Therapy for Patients With NSCLC Harbouring Sensitive Mutations of EGFR
Started Jun 2018
50 enrolled
Lung Cancer
A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer
Started Oct 2017
11 enrolled
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.