Breast Cancer
Neoprobe completes regulatory submission for Lymphoseek for breast and skin cancer biopsies
Published in Clinical Oncology Week, May 8th, 2006
Neoprobe Corporation (NEOP) announced that it has completed a submission to U.S. Food & Drug Administration (FDA) to respond to information requested by the FDA regarding both preclinical toxicity studies and the chemistry, manufacturing and control (CMC) issues surrounding the commercial production of Lymphoseek. Lymphoseek is intended to be used as a lymphatic tissue-targeting agent in biopsy procedures for the detection of lymph nodes in breast and melanoma cancers.
The submission to FDA included characterization studies of the drug substance, testing protocols and testing validation studies of the final drug product.
Dr. Richard Orahood,...
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