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Iressa (Gefitinib) - Summary

 
 



IRESSA SUMMARY

IRESSA®
(gefitinib)
TABLETS

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.


See all Iressa indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Iressa (Gefitinib)

FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer (NSCLC)
Source: Lung Cancer News From Medical News Today [2014.12.18]
The U.S. Food and Drug Administration has expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).

Scottish medicines consortium accepts the use of Alimta (pemetrexed) for maintenance treatment of non-small cell lung cancer
Source: Lung Cancer News From Medical News Today [2014.12.11]
On 8th December 2014, the Scottish Medicines Consortium accepted for use within NHS Scotland Alimta (pemetrexed) monotherapy for the maintenance treatment of locally advanced or metastatic...

Results of new drug, ASP8273, show response in patients with treatment-resistant NSCLC
Source: Lung Cancer News From Medical News Today [2014.11.25]
In a second presentation looking at new ways of treating non-small cell lung cancer (NSCLC) that has both the EGFR and T790M mutations, researchers tod the 26th EORTC-NCI-AACR1 Symposium on...

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.

more news >>

Published Studies Related to Iressa (Gefitinib)

Gefitinib for oesophageal cancer progressing after chemotherapy (COG): a phase 3, multicentre, double-blind, placebo-controlled randomised trial. [2014]
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. [2013]
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). [2013]
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. [2012]
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. [2012]
tyrosine-kinase inhibitors... INTERPRETATION: Although we recorded no benefit in terms of overall survival with

more studies >>

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 NSCLC patients.

more trials >>

Reports of Suspected Iressa (Gefitinib) Side Effects

Diarrhoea (17)Vomiting (10)Nausea (9)Dyspnoea (8)Rash (8)Cystitis Haemorrhagic (7)Death (7)Interstitial Lung Disease (7)Liver Disorder (6)Pleural Effusion (6)more >>


Page last updated: 2014-12-18

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