A possible lack of survival benefit for Tarceva in epidermal growth factor receptor-negative patients led FDA to require postmarketing studies addressing receptor status, despite OSI’s insistence that EGFR status is “not important,” review documents state.

AstraZeneca Iressa European Marketing Authorization Application withdrawn following the non-small cell lung cancer therapy’s failure to show a survival benefit in recent study. FDA is expected to provide an update on the status of gefitinib’s Subpart H approval in January or February

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011