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Article: FDA Panel Backs EGFR Drug From AstraZeneca For NSCLC.
- Article from:
- BIOWORLD Today
- Article date:
- November 4, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Washington Editor
SILVER SPRING, Md. - An FDA advisory panel provided late-stage lung cancer patients with a ray of hope Tuesday when it leaned toward recommending approval of Iressa, an epidermal growth factor receptor tyrosine kinase inhibitor.
The panel did not specifically vote on whether to recommend approval or not. Instead, the Oncologic Drugs Advisory Committee voted 11-to-3 that a 10 percent response rate from a 216-patient Phase II trial (Trial 39) submitted by London-based AstraZeneca plc for Iressa was "reasonable to predict clinical benefit in non-small-cell lung cancer." The application, filed under accelerated approval guidelines, seeks ...