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June 13, 2014
12:28 EDTNAVBNavidea confirms FDA approval of expanded use for Lymphoseek
Navidea Biopharmaceuticals announced that the FDA has approved the Supplemental New Drug Application for the expanded use of Lymphoseek Injection indicated for guiding sentinel lymph node biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity. Lymphoseek becomes the first and only FDA-approved radiopharmaceutical application for sentinel lymph node detection and was first approved in March 2013 for lymphatic mapping in breast cancer and melanoma patients.
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February 11, 2016
07:07 EDTNAVBNavidea enrolls first patient in Lymphoseek cervical cancer study
Navidea Biopharmaceuticals announced that the first patient has been enrolled in a clinical study evaluating Lymphoseek injection in women with known cervical cancer. The study, funded by a Fast-track grant from the National Institutes of Health, National Cancer Institute will assess the use of Lymphoseek in sentinel lymph node biopsy during cervical cancer surgery in support of the existing Lymphoseek label in lymphatic mapping. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Enrollment is currently planned in up to six sites throughout the U.S. The first patient has been enrolled by the principal investigator, Michael M. Frumovitz, M.D., M.P.H., Associate Professor, Department of Gynecologic Oncology and Reproductive Medicine, at The University of Texas MD Anderson Cancer Center. This multi-center, prospective, open-label study is designed to evaluate Lymphoseek(R) in patients with known cancer of the cervix. The trial intends to enroll up to 40 women with International Federation of Gynecology and Obstetrics IA2-IIA1 staging. Subjects will receive a single dose of Tc99m tilmanocept administered peritumorally approximately 1-2 hours before surgery. The results will report per-patient false negative rates and compare the pathology status of Lymphoseek-identified sentinel lymph nodes relative to the pathology status of non-sentinel lymph nodes in nodal staging of patients. Additionally, the study will report sensitivity, negative predictive value, and accuracy. Concordance and reverse concordance of identified nodes will be reported for the cases that use both Lymphoseek and a dye.
February 2, 2016
17:18 EDTNAVBNavidea provides update on Lymphoseek, Immunodiagnostics pipleline
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