gefitinib
gefitinib: developed by 1 company · 6 clinical trials tracked · 1 FDA decision.
gefitinib evidence translation
What we can confirm
1 FDA record · 6 tracked trials
What it means
What to watch
Prepared research question
How could gefitinib → AZN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (3)
| Company | Phase |
|---|---|
| ASTRAZENECA PLC (AZN) Locally Advanced or Metastatic EGFR Sensitising Mutation Pos… | Phase 3 |
| ASTRAZENECA PLC (AZN) | Approved |
| ASTRAZENECA PLC (AZN) | Approved |
Clinical Trials (6)
APPLE Trial: Feasibility and Activity of AZD9291 (Osimertinib) Treatment on Positive PLasma T790M in EGFR Mutant NSCLC Patients
Primary endpoint: PFS Rate at 18 Months
An Open-label, Multi-center, Global, Rollover Study for Patients Who Have Previously Been Treated With Capmatinib (INC280) as Monotherapy or in Combination in a Novartis Sponsored Trial.
Primary endpoint: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
A Phase 1/2 Study of Osimertinib in Combination With Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer
Primary endpoint: Number of patients completing combination therapy with gefitinib and osimertinib for 6 x 28 day cycles
A Phase Ib, Multi-center, Open Label Study of Ningetinib (CT053PTSA) in Combination With Gefitinib in Stage IIIB or IV NSCLC Patients With EGFR Mutation and T790M Negative Who Have Progressed After EGFR TKI Therapy
Primary endpoint: Part 1（dose-escalation part）: Maximum Tolerated Dose (MTD)
A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer.
Primary endpoint: Median Progression Free Survival (PFS) (Months)
A Phase I/II Study of Bexarotene in Combination With ZD 1839 (IRESSA) in the Third Line Treatment of Non-Small Cell Lung Cancer (NSCLC)
Primary endpoint: Overall response rate (RECIST CRITERIA), time to progression, toxicity
FDA Decisions1 records
Frequently asked questions
Who is developing gefitinib?
gefitinib is being developed by ASTRAZENECA PLC.
How many clinical trials involve gefitinib?
BioSniper tracks 6 clinical trials involving gefitinib.
What is gefitinib's latest FDA decision?
The most recent tracked FDA decision for gefitinib is Approval for 1 INDICATIONS AND USAGE IRESSA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14) ] . Limitation of Use: Safety and efficacy of IRESSA have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon , dated July 13, 2015.