Iressa Clinical Development Timeline
Executive Summary
Chronicle of the development and review of AstraZeneca’s tyrosine kinase inhibitor gefitinib for EGFR mutation-positive non-small cell lung cancer.
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How To Save A Drug: Iressa’s Return Relied On Consistency Across Totality Of Evidence
Drug Review Profile of the second life of AstraZeneca’s Iressa shows how FDA adapts to imperfect but improving information without putting undue burden on sponsors – and how the agency recently applied a similar iterative approach to another EGFR inhibitor, Astellas and Genentech’s Tarceva.
Chart: Iressa Clinical Development
Iressa Clinical Development
AstraZeneca Iressa Link To Interstitial Lung Disease Questioned In Review
Iressa’s link to interstitial lung disease is uncertain given the similar rate of ILD seen in patients receiving the AstraZeneca drug and placebo, FDA Office of Drug Evaluation I Director Robert Temple, MD, states in a "Feb. 19 review memo.