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)
Lung Cancer: Expanded Alimta Label
Source: MedPage Today Product Alert [2012.10.19]
WASHINGTON -- The FDA has expanded the indication for the cancer drug pemetrexed injection to act as a maintenance therapy with cisplatin for nonsquamous non-small cell lung cancer.
Published Studies Related to Iressa (Gefitinib)
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
Afatinib versus placebo for patients with advanced, metastatic non-small-cell
lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines
of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. 
tyrosine-kinase inhibitors... INTERPRETATION: Although we recorded no benefit in terms of overall survival with
Clinical Trials Related to Iressa (Gefitinib)
Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer [Active, not recruiting]
Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia [Active, not recruiting]
The purpose of this study is to determine how effective, and to what extent, Iressa is in the
treatment of acute myelogenous leukemia.
Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment [Active, not recruiting]
The purpose of this study is to provide gefitinib treatment to patients who, on completion or
closure of other gefitinib clinical studies, were either receiving placebo treatment, or are
continuing on the same dose and regimen of gefitinib established in their preceding study,
for as long as the patients continue to derive benefit.
Open-Label Extension of Other SZ1839 (Iressa) Trials [Completed]
A trial to assess patients who have been treated with Iressa in a previous clinical trial and
may benefit from continued treatment with Iressa.
First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia [Active, not recruiting]
The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet
chemotherapy given as first line treatment in terms of progression free survival in selected
Reports of Suspected Iressa (Gefitinib) Side Effects
Cystitis Haemorrhagic (7),
Interstitial Lung Disease (7),
Liver Disorder (6),
Pleural Effusion (6), more >>
Page last updated: 2014-11-30