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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)

Merck discontinues clinical development program of tecemotide as a monotherapy in Stage III non-small cell lung cancer
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.09.15]
Merck has announced that its biopharmaceutical division Merck Serono will discontinue the clinical development program of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide...

High concordance between EGFR mutations from circulating-free tumor DNA and tumor tissue in non-small cell lung cancer
Source: Lung Cancer News From Medical News Today [2014.08.26]
Epidermal growth factor receptor (EGFR) mutations found in the circulating free tumor DNA (ctDNA) from the plasma of advanced non-small cell lung cancer (NSCLC) patients correlates well with the EGFR...

In advanced non-small cell lung cancer, BIM deletion predicts survival
Source: Lung Cancer News From Medical News Today [2014.08.26]
Bcl-2-like protein 11 (BIM) deletion in advanced non-small cell lung cancer (NSCLC) is associated with shorter progression free survival (PFS) in epidermal growth factor receptor (EGFR) tyrosine...

Surgery may yield better long-term results for some lung cancer patients
Source: Lung Cancer News From Medical News Today [2014.09.19]
Patients with early stage non-small cell lung cancer (NSCLC) who are otherwise healthy fare better over time if they undergo conventional surgery versus less-invasive radiosurgery to remove their...

Some stage IV lung cancer patients achieve long-term survival after aggressive treatments
Source: Lung Cancer News From Medical News Today [2014.09.19]
A large, international analysis of patients with stage IV non-small cell lung cancer (NSCLC) indicates that a patient's overall survival (OS) rate can be related to factors including the timing of...

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Published Studies Related to Iressa (Gefitinib)

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

Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS). [2011.07.20]
PURPOSE: The results of the Iressa Pan-Asia Study (IPASS), which compared gefitinib and carboplatin/paclitaxel in previously untreated never-smokers and light ex-smokers with advanced pulmonary adenocarcinoma were published previously. This report presents overall survival (OS) and efficacy according to epidermal growth factor receptor (EGFR) biomarker status... CONCLUSION: EGFR mutations are the strongest predictive biomarker for PFS and tumor response to first-line gefitinib versus carboplatin/paclitaxel. The predictive value of EGFR gene copy number was driven by coexisting EGFR mutation (post hoc analysis). Treatment-related differences observed for PFS in the EGFR mutation-positive subgroup were not apparent for OS. OS results were likely confounded by the high proportion of patients crossing over to the alternative treatment.

A phase II randomized trial of gefitinib alone or with tegafur/uracil treatment in patients with pulmonary adenocarcinoma who had failed previous chemotherapy. [2011.06]
BACKGROUND: Tegafur/uracil (UFT) is suitable for metronomic chemotherapy because of its underlying antiangiogenesis mechanism. This study aimed to assess the efficacy of adding daily oral UFT to gefitinib treatment in patients with pulmonary adenocarcinoma who had failed previous chemotherapy... CONCLUSION: Gefitinib plus UFT treatment had better PFS than gefitinib alone treatment. Gefitinib is effective in patients with EGFR mutations, and the addition of UFT treatment produced better PFS in these patients with mutations.

Gefitinib versus docetaxel in previously treated advanced non-small-cell lung cancer: a meta-analysis of randomized controlled trials. [2011.05]
PURPOSE: A meta-analysis of randomized controlled trials was performed to compare the efficacy, quality of life (QOL), symptom improvement and toxicities of gefitinib with docetaxel in previously treated advanced non-small-cell lung cancer... CONCLUSIONS: In conclusion, although similar OS and PFS, gefitinib showed an advantage over docetaxel in terms of objective response rate, QOL and tolerability. Therefore, gefitinib is an important and valid treatment option for previously treated advanced non-small-cell lung cancer patients.

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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: 2014-09-19

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