United States of America - The Food and Drug Administration (FDA) has reported that a large clinical trial comparing gefitinib (Iressa®) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer therapy showed no survival benefit. Patients currently taking gefitinib should consult their physicians as soon as possible; patients should not change their therapy without first consulting their physicians.

Alternative therapies are available. FDA has approved docetaxel (Taxotere®) and erlotinib (Tarceva®), both of which have been shown in studies to improve survival in patients with non-small cell lung cancer whose cancer has progressed while on previous therapies. Pemetrexed (Alimta®) has received an accelerated approval based on the surrogate endpoint for this use but has not yet demonstrated any survival benefit.

FDA approved gefitinib in 2003 under the Agency’s accelerated approval program for the treatment of patients with non-small cell lung cancer who had failed two or more courses of chemotherapy. Gefitinib was approved because the data from clinical trials showed that it caused significant shrinkage in tumours in about 10% of patients, and this was thought likely to increase patients’ overall survival time.

After the approval of gefitinib, the manufacturer conducted a study in approximately 1700 patients to determine whether the drug would in fact prolong survival in comparison to patients taking placebo. The results announced indicate that the drug did not prolong survival. FDA will determine whether gefitinib should be withdrawn from the market or if other regulatory actions are appropriate after it has evaluated the recent study results.

Reference: FDA statement.(revised version). 17 December 2004. http://www.fda.gov/medwatch/