Lymphoseek Now Approved for SLN Mapping in Breast Cancer

Lymphoseek Now Approved for SLN Mapping in Breast Cancer
Navidea Biopharmaceuticals, Inc. will now be able to market its product, Lymphoseek (technetium Tc 99m tilmanocept), as an injection for lymphatic mapping in solid tumors and sentinel lymph node (SLN) detection in breast cancer and melanoma. The Food and Drug Administration expanded its approval for these two cancers, increasing cancer types beyond the previous head and neck cancers with squamous cell carcinoma of the oral cavity, and also approved Lymphoseek with or without scintigraphic imaging to map lymph nodes pre-operatively to facilitate locating nodes during surgery. "We are highly encouraged by the expanded FDA approval and believe that Lymphoseek now has the potential to become a standard-of-care in lymphatic mapping and SLN biopsy for the staging and prognosis of upwards of 1.2 million patients diagnosed with solid tumors annually in the US," said Michael Goldberg, MD, interim chief executive officer of Navidea, in a company's news release. Approval was contingent upon several phase 3 clinical trials comparing Lymphoseek to vital blue dye (VBD), the current standard for node detection. Two studies of 148 total breast cancer patients indicated an agreement between the two detectors of 99.04%. Of the 209 SLNs detected by VBD, Lymphoseek detected 207. Another two studies with 154 total melanoma patients showed an agreement rate of 98.7%. Lymphoseek detected 232 of the 235 SLNs detected with VBD. However, Lymphoseek detected all 45 melanoma-positive SLNs, whereas VBD detected only 80%. Injection site irritation was reported by only four (0.7%) patients, and only one (0.2% patient reported patin at the injection site. No serious adverse events have been reported with the use of Lymphoseek. "The ability of Lymphoseek to accurately identify SLNs in pati
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