ODAC Votes for Accelerated Approval of Iressa for NSCLC

October 1, 2002

n ROCKVILLE, Maryland-The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11 to 3 that phase II results of AstraZeneca Pharmaceuticals’ EGFR tyrosine kinase inhibitor Iressa (ZD1839, gefitinib) as third-line therapy for advanced non-small-cell lung cancer (NSCLC) were "reasonably likely to predict clinical benefit." The FDA considers this a recommendation for accelerated approval. Look for a complete report of the ODAC decision and a review of the phase II trials of Iressa in NSCLC in next month’s issue of ONI.

n ROCKVILLE, Maryland—The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11 to 3 that phase II results of AstraZeneca Pharmaceuticals’ EGFR tyrosine kinase inhibitor Iressa (ZD1839, gefitinib) as third-line therapy for advanced non-small-cell lung cancer (NSCLC) were "reasonably likely to predict clinical benefit." The FDA considers this a recommendation for accelerated approval. Look for a complete report of the ODAC decision and a review of the phase II trials of Iressa in NSCLC in next month’s issue of ONI.