AZ's Iressa returning to U.S. market

FDA granted marketing approval to AstraZeneca plc (LSE:AZN; NYSE:AZN) for Iressa gefitinib as first-line therapy for metastatic non-small cell lung cancer (NSCLC) patients whose tumors have epidermal growth factor receptor ( EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by the companion diagnostic therascreen EGFR RCQ PCR kit from Qiagen N.V. (Xetra:QIAl; NASDAQ:QGEN).

AstraZeneca spokesperson Michele Meixell told BioCentury the pharma aims to have Iressa available by next week, and that the drug's U.S. price will be "comparable to other first generation TKIs." Iressa has Orphan Drug status for the indication. ...