A US Food and Drug Administration advisory panel is set to convene on March 4 to decide the fate of AstraZeneca’s non-small cell lung cancer agent, Iressa (gefitinib), which has become the subject of much scrutiny since failing to show a survival advantage in a recent clinical trial [[20/12/04b]].
The agency will decide whether to rescind Iressa’s approval status in the wake of the 1,692-patient trial, known as Isel, which included NSCLC patients who had failed other courses of cancer therapy, showing that Iressa failed to significantly prolong survival compared to placebo, or whether other regulatory action will be appropriate.
AstraZeneca will likely present results of an additional survival analysis currently being conducted, at the meeting. In addition to subgroup analyses, the company is “committed to performing, at the request of the independent data monitoring committee, a further survival analysis with a cut-off point at the end of the month,” the FDA quotes AstraZeneca’s executive director of development, John Patterson, as saying last month.
Since release of the trial results in mid-December, AstraZeneca has halted detailing the drug and withdrawn its European marketing application for NSCLC [[05/01/05a]].
However, AstraZeneca says that no regulatory decision is anticipated at this particular meeting, as full analysis of the complete data set will not have been completed. Similarly, consideration of other regulatory actions, such as removal of the drug from the market, is not anticipated until the data are fully analysed.