Lymphoseek meets primary endpoint in SCCHN patients

Navidea Biopharmaceuticals Inc. (NYSE-M:NAVB) said preoperative imaging with a single injection of Lymphoseek tilmanocept met the primary endpoint in the Phase III NEO3-06 trial to detect sentinel lymph nodes in over 80 patients with squamous cell carcinoma of the head and neck (SCCHN). Specifically, in the 39 patients determined to have pathology-positive lymph nodes through a full regional nodal dissection, Lymphoseek accurately identified 38 sentinel lymph nodes for an overall false negative rate of 2.56% (p=0.0205). Based on the data, the trial's DSMC recommended closing the trial early.

Navidea said it will evaluate submitting an sNDA to FDA for the SCCHN indication this year. FDA approved an NDA for Lymphoseek for use in intraoperative lymphatic imaging in breast cancer and melanoma patients last month. Navidea submitted an MAA to EMA for the product in December. The company said the MAA covers the use of Lymphoseek for general lymphatic mapping and is not restricted to any particular solid tumor type (see BioCentury Extra, March 13). ...