March 7, 2014 — Navidea Biopharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review an additional Supplemental New Drug Application (sNDA) for the proposed expanded label for Lymphoseek (technetium 99m tilmanocept) Injection to support broader and more flexible use in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other optimization capabilities. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target review date for the second Lymphoseek sNDA of Oct. 16, 2014.
The two Lymphoseek sNDAs now accepted are derived from a single, data-rich application submitted to FDA in December 2013. In assessing the application, FDA chose to separate the filing in two based on the proposed labeling extensions requested and the scope of information provided. This second sNDA application is aimed at expanding the Lymphoseek label to support more flexible utilization practices for Lymphoseek in lymphatic mapping and lymphoscintigraphy imaging. The first sNDA, aimed at Lymphoseek’s use as a sentinel lymph node detection agent in patients with head and neck cancer, received FDA Fast Track designation and was accepted for Priority Review, as previously announced, with a PDUFA date target of June 16, 2014. 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.
“The FDA’s decision to review an additional sNDA to further expand Lymphoseek’s labeling underscores our belief that the agent can make a critical difference for patients as part of their overall diagnosis and treatment,” commented Cornelia Reininger, M.D., Ph.D., Navidea’s senior vice president and chief medical officer. “Additionally, the FDA’s decision to grant Priority Review for our first Lymphoseek sNDA focused on sentinel lymph node (SLN) detection in patients with head and neck cancer supports recognition that Lymphoseek-guided SLN detection in this disease can have a significant impact on morbidity. Label expansion for these sNDAs, if approved, may allow for broader cancer-type use, enable more consistent and standardized lymphatic mapping and lymphoscintigraphy analysis, and address important areas of unmet medical need.”
The second Lymphoseek sNDA seeks to expand product claims to enable broader and more flexible utilization of the agent in routine practice, including lymphoscintigraphy imaging and flexible timing of Lymphoseek administration allowing for a 2-day protocol. Data submitted in support of these parameters were derived from Navidea’s series of prospective, well-controlled Phase 3 studies in patients with breast cancer, head and neck cancer, and melanoma. These study results demonstrated the ability of Lymphoseek to detect lymph nodes in same-day or subsequent-day surgery following injection, as well as being used in lymph node imaging, or lymphoscintigraphy.
For more information: www.navidea.com