Statement of Dr. Diana Zuckerman At the FDA General and Plastic Surgery Devices Advisory Panel on ProSense Cryoablation System

November 7, 2024: We testified at an FDA Advisory Panel meeting to advise FDA whether ProSense Cryoablation can replace lumpectomy for older women with very early, low-risk breast cancer. This technique can freeze and destroy a tumor in a few minutes but the research was not well-designed to determine if it is as safe as lumpectomy, and if so, for which types of patients.

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Testimony of Grace Drew at the FDA Advisory Committee Meeting on Imfinzi for Resectable Non-Small Cell Lung Cancer

July 25, 2024: At the FDA Advisory Committee meeting on a new indication for Imfinzi (durvalumab), NCHR pointed out that the AEGEAN clinical trial did not assess if Imfinzi is necessary both before and after lung tumor surgery. We strongly support the FDA scientists who stated that the trials need to be redesigned to determine whether Imfinzi both before and after surgery is more beneficial compared to Imfinzi either before or after surgery.

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