Iressa Approved for Non-Small Cell Lung Cancer
July 13, 2015 – The U.S. Food and Drug Administration (FDA) approved Iressa (gefitinib) a tyrosine kinase inhibitor (TKI),for the first-line treatment of patients with metastatic non-small cell lung cancer (NCSLC) 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 manufactured by AstraZeneca,
AstraZeneca first received accelerated approval from the FDA in May 2003 for Iressa as a third-line treatment of advanced NSCLC in patients who have benefitted from Iressa treatment. Withdrawal of this approval followed in April 2012 when AstraZeneca failed to conduct post marketing studies confirming its benefits.
The recommended dose for the recently approved Iressa is 250mg once daily. Iressa will be available through a limited network of specialty pharmacies. Each year in the U.S, approximately 220,000 patients are diagnosed with lung cancer, NSCLC being the most common type, accounts for approximately 85% of cases. At least 10% of NSCLC tumors have EGFR gene mutations. The annual cost is estimated to be around $72,000, however pricing has not yet been released.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
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