AstraZeneca Could Seek New Indication For Iressa In Europe
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
AstraZeneca Iressa European Marketing Authorization Application withdrawn following the non-small cell lung cancer therapy’s failure to show a survival benefit in recent study. FDA is expected to provide an update on the status of gefitinib’s Subpart H approval in January or February
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AstraZeneca is considering filing for a new indication for Iressa in Europe in the wake of its decision to withdraw a European Marketing Authorization Application for the lung cancer therapy. AstraZeneca announced the withdrawal of its MAA for Iressa (gefitinib) in patients with non-small cell lung cancer Jan. 4. "The submission of a new MAA will be considered for Iressa in the future, after evaluation of the full" Iressa Survival Evaluation in Lung cancer trial "dataset and emerging data," AstraZeneca said. The decision to withdraw the European application comes on the heels of Iressa's failure to demonstrate a survival benefit in the ISEL trial. AstraZeneca has suggested inappropriate dose selection may have contributed to the negative results. AstraZeneca "has taken this decision after consultation with" the European Medicines Agency "in view of the [ISEL] survival results, which will not meet the approval requirements for the current Iressa MAA." AstraZeneca is conducting Phase II trials of gefitinib in treatment of brain and neck tumors, and in breast and esophageal cancer. The company said it does not plan to alter the Phase II program for Iressa monotherapy in light of the ISEL results; development programs using Iressa as an add-on or comparator may need to be changed, the firm indicated. Iressa is approved for treatment of NSCLC in the U.S. and Japan, among other countries. AstraZeneca said that discussions are ongoing with FDA and foreign regulatory authorities concerning Iressa's status. FDA is expected to provide an update on the status of Iressa's subpart H licensure in January or February. Loss of accelerated approval would put the drug back in IND status. Iressa's original review was complicated by negative trial results in the first-line setting ( 1 , p. 30). One forum the agency could use to review Iressa's status is the first round of meetings of its Oncologic Drugs Advisory Committee, which are tentatively scheduled for March 2-3 [Editor's Note: For information on upcoming advisory committee meetings, visit FDAAdvisoryCommittee.com.] ¨¨ |