ROCKVILLE, MarylandThe Food and Drug Administration (FDA) has granted
accelerated approval to Iressa tablets (gefitinib, AstraZeneca) as
monotherapy for the treatment of advanced non-small-cell lung cancer (NSCLC)
in patients whose disease has progressed despite treatment with
platinum-based and docetaxel (Taxotere) chemotherapy.
The Oncologic Drugs Advisory Committee (ODAC) had recommended approval of
Iressa on September 24, 2002. However, the FDA delayed action on the
recommendation for 3 months to analyze new Japanese data that indicated
Iressa was associated with an unexpected and often-fatal rate of interstitial
lung disease (ILD).