Oncologic Drugs Committee to Discuss Iressa

AstraZeneca's cancer treatment Iressa will be a main topic of discussion at next month's meeting of the FDA's Oncologic Drugs Advisory Committee, which will examine a recent clinical trial that raised questions about the drug's effectiveness.

The FDA last month said it intended to take a close look at the "Iressa Survival Evaluation in Lung Cancer" (ISEL) trial, which failed to show that Iressa (gefitinib) significantly prolonged survival in lung-cancer patients compared to a placebo. As part of the announcement, the agency urged patients taking Iressa to consult their physicians immediately and recommended several FDA-approved alternatives to the drug, including Taxotere (docetaxel) and Tarceva (erlontinib HCl).

The oncologic drugs panel will convene March 4 to discuss the ISEL research, but the committee is not expected to make a final decision on Iressa's future.

For more information about the advisory committee meeting, go to http://www.fda.gov/oc/advisory/accalendar/2005/cder12542dd03030405.html (http://www.fda.gov/oc/advisory/accalendar/2005/cder12542dd03030405.html).