AstraZeneca pulls European Iressa application
AstraZeneca has taken this decision after consultation with the EMEA in view of the Iressa survival evaluation in lung cancer (ISEL) survival results, which will not meet the approval requirements for the current Iressa (gefitinib) marketing authorization application (MAA). The submission of a new MAA will be considered for Iressa in the future, after evaluation of the full ISEL dataset and emerging data. In the preliminary analysis of the ISEL trial, there was a statistically significant improvement in tumor shrinkage (response rate) and time to treatment failure, which did not translate into a statistically significant survival benefit. In the meantime, AstraZeneca believes it would be premature to close the Iressa compassionate use (expanded access) program to new patients until the full ISEL dataset is reviewed, as the company remains convinced by the evidence that Iressa provides some benefit for patients with non-small cell lung cancer (NSCLC). The status of all ongoing AstraZeneca-sponsored studies in NSCLC is under review. Investigator and co-operative groups have been informed, all trials are open to recruitment and are being reviewed on a trial by trial basis. Studies in other cancer types are set to continue. Discussions with the FDA, MHLW in Japan and all other Regulatory Authorities continue about the status of Iressa.