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March 13, 2013
13:09 EDTNAVB, CAHFDA approves Navidea Lymphoseek injection for use in lymphatic mapping
Navidea Biopharmaceuticals (NAVB) announced U.S. Food and Drug Administration approval of Lymphoseek Injection, a novel product indicated for use in lymphatic mapping procedures to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. Lymphoseek will be sold and distributed in the U.S. on an exclusive basis by Cardinal Health (CAH).
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March 25, 2015
11:45 EDTCAHLeerink healthcare tech/pharma analysts hold analyst/industry conference call
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07:32 EDTNAVBNavidea to present Lymphoseek injection data at SSO meeting
Navidea Biopharmaceuticals announced that data from its Lymphoseek injection studies in melanoma, breast and oral cavity squamous cell cancers will be presented at the 68th Annual Cancer Symposium of the Society of Surgical Oncology meeting held in Houston, TX, March 25-28. An oral presentation by Douglas Chepeha, M.D. of the University of Toronto-Princess Margaret Hospital reveals that analysis from Phase 3 data for detection of sentinel lymph nodes in head and neck oral cavity squamous cell carcinoma patients demonstrated high concordance between preoperative lymphoscintigraphy and intraoperative SLN biopsy findings. Notably, 95.2% of patients had agreement between their preoperative and intraoperative findings. This high concordance when using Lymphoseek confirms its role in the utility of preoperative lymphoscintigraphy imaging for planning and conducting SLN biopsy. Results of a follow-up outcome study presented as a poster by Julian Kim, M.D. of the University Hospitals Seidman Cancer Center indicated that in patients who were confirmed to be node-negative after sentinel lymph node biopsy the regional recurrence-free ratewas 98.8% at three years. An overall false negative rate for the two tumor types was 5.6% and the negative predictive value was 98.6%. These results demonstrate that Lymphoseek accurately identified SLNs and is likely predictive of pathological staging.

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