FDA approves Lymphoseek for all solid tumors

The Food and Drug Administration has approved a Supplemental New Drug Application for the expanded use of Lymphoseek for lymphatic mapping in all solid tumors. The approval also adds sentinel lymph node detection for melanoma and breast cancer.

Lymphoseek injection (technetium Tc 99m tilmanocept, Navidea Biopharmaceuticals) now is indicated for lymphatic mapping with a hand-held gamma counter to locate lymph nodes draining a primary tumor site in patients who have solid tumors, according to a news release. The injection is also indicated for guiding sentinel lymph node biopsy (SLNB) with a hand-held gamma counter in patients who have clinically node negative squamous cell carcinoma (SCC) of the oral cavity, breast cancer or melanoma.

The FDA’s approval allows expanded utilization of the injection either with or without lymphoscintigraphy to enable preoperative imaging and lymph node mapping to facilitate node localization during surgery, according to the company. Lymphoseek is the only FDA-approved agent for lymphatic mapping of solid tumors.

The expanded approval was the result of data from Navidea’s combined analysis of prospective phase 3 trials in breast cancer, melanoma and head and neck cancers from more than 500 patients. Data from three studies demonstrated positive diagnostic performance of Lymphoseek across the tumor types that were studied, the company states.

The FDA also has outlined a postmarketing requirement for the initiation of a pediatric study of solid tumor cancer. That has a target date for submission in 2018.

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