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Navidea Biopharmaceuticals Inc announces presentation of Lymphoseek three-year recurrence and survival outcomes after Sentinel Lymph Node Biopsy in Patients with Breast Cancer and Melanoma


Friday, 14 Mar 2014 07:30am EDT 

Navidea Biopharmaceuticals Inc:Results of three-year, voluntary follow-up study of Lymphoseek (technetium Tc 99m tilmanocept) Injection conducted in patients who participated in a Phase 3 clinical trial (NEO3-05) of the product.Primary objective of follow-up study was to determine regional recurrence-free rate (RRFR) after sentinel lymph node biopsy with Lymphoseek.Results of follow-up study indicated that in patients who were confirmed to be node-negative (N0) after sentinel lymph node biopsy RRFR was 98.8% and disease-specific survival rate (DSSR) was 98.6% at three years.Lymphoseek is receptor-targeted, small-molecule radiopharmaceutical approved by the U.S. Food and Drug Administration for use in lymphatic mapping to assist in localization of lymph nodes draining primary tumor in patients with breast cancer or melanoma Findings.From Lymphoseek follow-up study compare favorably with outcomes from previously reported data from other studies.Study reported in New England Journal of Medicine which evaluated use of sentinel node biopsy or nodal observation node-negative (N0) melanoma patients showed a DSSR at three years of 90.1%.In another study published in Lancet Oncology (2), node-negative (N0) breast cancer patients had an estimated disease-free survival rate at five years of 88.6%. 

Company Quote

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