FDA Approved AstraZeneca’s Gefitinib (Iressa)
AstraZeneca recently received approval from the Food and Drug Administration for IRESSA® (gefitinib) as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. IRESSA is approved in 91 countries for the treatment of adult patients with metastatic EGFR mutation-positive NSCLC.
Select Safety Information
- Interstitial Lung Disease (ILD): ILD occurred in patients taking IRESSA. Withhold IRESSA for worsening of respiratory symptoms. Discontinue IRESSA if ILD is confirmed
- Hepatotoxicity: Obtain periodic liver function testing. Withhold IRESSA for Grade 2 or higher for alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevations. Discontinue for severe hepatic impairment
- The most commonly reported adverse drug reactions, reported in more than 20% of the patients and greater than placebo, were skin reactions and diarrhea
Click here for full Prescribing Information.
Additional information about IRESSA is available at https://www.iressa-usa.com.
More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm454692.htm
