GEFITINIB

Post-LOESM

gefitinib

Teva

ANDAORALTABLET

Approved

Apr 2023

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

GEFITINIB (gefitinib) by Teva is protein kinase inhibitors [moa]. First approved in 2023.

Drug data last refreshed 19h ago

$0.0BPart D

Mechanism of Action

Protein 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)

NCT04143607Phase 3Active Not Recruiting

ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC

Started Jul 2019

337 enrolled

Locally Advanced or Metastatic NSCLC

NCT03599518Phase 1Terminated

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

NCT03529084Phase 3Withdrawn

Phase III Study of Nazartinib (EGF816) Versus Erlotinib/Gefitinib in First-line Locally Advanced / Metastatic NSCLC With EGFR Activating Mutations

Started Jul 2018

Carcinoma, Non-small Cell Lung

NCT03381430N/AUnknown

Gefitinib Combine Radiotherapy as Therapy for Patients With NSCLC Harbouring Sensitive Mutations of EGFR

Started Jun 2018

50 enrolled

Lung Cancer

NCT03292133Phase 2Terminated

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.