Iressa black box sought

Executive Summary

Public Citizen requests that FDA add a black box warning to Iressa labeling "to state that the drug should be reserved for the same group of patients who were studied in the Phase II trial on which approval was based." FDA approved AstraZeneca's Iressa (gefitinib) for the treatment of advanced non-small cell lung cancer May 5 (1"The Pink Sheet" May 12, p. 3). A black box warning should communicate to "patient[s] that they may be at risk of a fatal lung disease unrelated to NSCLC," Public Citizen says in May 15 letter to Commissioner McClellan. FDA was understood to be considering a black box warning until very late in the review cycle for the drug...