IRESSA® (gefitinib tablets) contain 250 mg of gefitinib and are available as brown film-coated tablets for daily oral administration.
IRESSA is indicated as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies.
The effectiveness of IRESSA is based on objective response rates (see CLINICAL PHARMACOLOGY Clinical Studies section). There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Results from two large, controlled, randomized trials in first-line treatment of non-small cell lung cancer showed no benefit from adding IRESSA to doublet, platinum-based chemotherapy. Therefore, IRESSA is not indicated for use in this setting.
Media Articles Related to Iressa (Gefitinib)
Iressa Approved for Specific Late-Stage Lung Cancer
Source: MedicineNet Lung Cancer Specialty [2015.07.14]
Title: Iressa Approved for Specific Late-Stage Lung Cancer
Category: Health News
Created: 7/13/2015 12:00:00 AM
Last Editorial Review: 7/14/2015 12:00:00 AM
FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer
Source: Lung Cancer News From Medical News Today [2015.07.14]
The U.S. Food and Drug Administration has approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types...
Nine-gene molecular prognostic index can provide accurate survival stratification in patients with early-stage non-small cell lung cancer
Source: Lung Cancer News From Medical News Today [2015.08.19]
A nine-gene molecular prognostic index (MPI) for patients with early-stage non-small cell lung cancer (NSCLC) was able to provide accurate survival stratification and could potentially inform the...
Nine-gene MPI can provide accurate survival stratification in patients with non-small cell lung cancer
Source: Lung Cancer News From Medical News Today [2015.08.19]
A nine-gene molecular prognostic index (MPI) for patients with early-stage non-small cell lung cancer (NSCLC) was able to provide accurate survival stratification and could potentially inform the use...
Afatinib: Added benefit in certain mutations confirmed
Source: Lung Cancer News From Medical News Today [2015.08.21]
Afatinib (trade name: Giotrif) has been approved since September 2013 for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGF...
Published Studies Related to Iressa (Gefitinib)
Fuzheng Kang'ai decoction combined with gefitinib in advanced non-small cell lung
cancer patients with epidermal growth factor receptor mutations: study protocol
for a randomized controlled trial. 
BACKGROUND: Patients with advanced non-small cell lung cancer (NSCLC) harboring
mutations of the epidermal growth factor receptor (EGFR) gene respond well to the
EGFR tyrosine kinase inhibitor (TKI) gefitinib... This study will provide objective evidence
to evaluate the efficiency of CHM combined with gefitinib in NSCLC patients with
EGFR mutations, and may provide a novel regimen for patients with NSCLC.
Gefitinib for oesophageal cancer progressing after chemotherapy (COG): a phase 3,
multicentre, double-blind, placebo-controlled randomised trial. 
advanced oesophageal cancer... INTERPRETATION: The use of gefitinib as a second-line treatment in oesophageal
Icotinib versus gefitinib in previously treated advanced non-small-cell lung
cancer (ICOGEN): a randomised, double-blind phase 3 non-inferiority trial. 
with non-small-cell lung cancer... INTERPRETATION: Icotinib could be a new treatment option for pretreated patients
Symptom and quality of life benefit of afatinib in advanced non-small-cell lung
cancer patients previously treated with erlotinib or gefitinib: results of a
randomized phase IIb/III trial (LUX-Lung 1). 
in a double-blind, randomized, phase IIb/III trial (LUX-Lung 1)... CONCLUSION: In the LUX-Lung 1 trial, the addition of afatinib to BSC
Gefitinib versus placebo as maintenance therapy in patients with locally advanced
or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804): a multicentre,
double-blind randomised phase 3 trial. 
setting... INTERPRETATION: Maintenance treatment with gefitinib significantly prolonged
Clinical Trials Related to Iressa (Gefitinib)
Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer [Completed]
Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia [Completed]
The purpose of this study is to determine how effective, and to what extent, Iressa is in
the treatment of acute myelogenous leukemia.
An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma [Completed]
This study is a multicentre, open label, non-comparative, two stage phase II trial to assess
the activity of ZD1839 (IRESSA) in patients with malignant mesothelioma. Patients will
receive trial treatment as first-line therapy, administered continuously once daily until
the completion of six 4-week cycles of treatment, disease progression, unacceptable toxicity
or withdrawal of consent. Patients continuing to show evidence of response, disease
stabilization or clinical benefit from ZD1839 may continue to receive therapy beyond
completion of the trail.
Arimidex/Faslodex/Iressa Study: A Trial Using Arimidex, Faslodex and Iressa in Women With Breast Cancer [Terminated]
The investigators want to know if combining Arimidex and Faslodex with Iressa will be an
effective treatment for breast cancer. They also want to know, using special tests on the
tumor, the changes that occur with the treatment so they can try to improve their treatment
for breast cancer in the future.
Gefitinib in Treating Patients Who Are Undergoing Surgery and/or Radiation Therapy for Locally Advanced or Recurrent Squamous Cell Skin Cancer [Completed]
The goal of this clinical research study is to learn if giving Iressa (Gefitinib or ZD1839)
with surgery and/or radiation will help to control squamous cell carcinoma of the skin. The
safety of this treatment will also be studied
Reports of Suspected Iressa (Gefitinib) Side Effects
Cystitis Haemorrhagic (7),
Interstitial Lung Disease (7),
Liver Disorder (6),
Pleural Effusion (6), more >>