BioCentury
ARTICLE | Company News

ODAC to review Iressa status

March 3, 2005 3:33 AM UTC

FDA's Oncologic Drugs Advisory Committee will receive a briefing Friday from AstraZeneca (LSE:AZN; AZN) about preliminary data from a confirmatory trial in which Iressa gefitinib did not provide a survival benefit in non-small cell lung cancer (NSCLC) patients who had failed chemotherapy (see BioCentury, Dec. 20, 2004). Iressa received accelerated approval in May 2003 based on tumor response data, contingent on AZN's commitment to conduct Phase IV trials to confirm clinical benefit.

The panel will discuss the company's decision to inform physicians of the preliminary data and to keep the EGFR kinase inhibitor on the market pending a full analysis of the trial. AZN said it wanted to preserve access for the 15,000 patients currently receiving the drug. The full analysis will be available in May or June. ...