Date: 2015-02-18
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the International Conference on Innovative Approaches in Head and Neck Oncology
Company: Navidea Biopharmaceuticals (USA - OH)
Product: Lymphoseek® (technetium Tc 99m tilmanocept)
Action
mechanism: radiopharmaceutical. Lymphoseek® (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer, in patients with breast cancer or melanoma.
Disease: sentinel lymph node biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On February 18, 2015, Navidea Biopharmaceuticals reported that a Lymphoseek® (technetium Tc 99m tilmanocept) injection presentation at the International Conference on Innovative Approaches in Head and Neck Oncology contributes to a growing body of data reinforcing the clinical value of Lymphoseek®, specifically for guiding sentinel lymph node biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity. The data, presented by Remco de Bree, M.D., Ph.D. head and neck surgeon from the VU University Medical Center, The Netherlands, included the following: Lymphoseek® is uniquely suited to identify the sentinel lymph node where the injection site is in very close proximity
Previously reported clinical trial data, which were used to obtain European approval in 2014 and which demonstrated a 2.56% false negative rate for sentinel lymph node detection compared to the gold standard of post-operative histopathology
There was no observable difference in Lymphoseek® performance when used either the day prior to or the day of surgery
Lymphoseek® displayed a favorable safety profile and delivered rapid and consistent injection site clearance and localization to sentinel nodes.
