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February 18, 2014
07:36 EDTNAVBNavidea announces priority review for sNDA to expand Lymphoseek labeling
Navidea Biopharmaceuticals announced that the U.S. Food and Drug Administration has accepted the Supplemental New Drug Application and granted a Priority Review for the expanded use of Lymphoseek Injection indicated for sentinel lymph node detection in patients with head and neck cancer. Under the Prescription Drug User Fee Act, the FDA has set a target review date for the Lymphoseek sNDA of June 16. The FDA grants priority review status to drug applications that may offer a significant improvement in treatment over existing options. Lymphoseek is currently approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor in patients with breast cancer and melanoma.
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March 25, 2015
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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