Approval of the Lymphoseek system for detecting sentinel lymph nodes has been extended to cover all solid-tumor cancers, its manufacturer said Wednesday.
The FDA is also permitting the radiolabeled tracer system to also now be used with or without lymphoscintigraphy, according to Navidea Biopharmaceuticals.
Previously, Lymphoseek had been approved in conjunction with melanomas, breast cancers, and head and neck tumors.
The product uses a technetium-99 labeled tracer to identify lymph nodes serving areas near primary tumors, allowing oncologists to select for excision and analysis those nodes most likely to harbor emigrating cancer cells. The tracer is called tilmanocept, and it binds to CD206 receptors in lymph nodes.
Navidea said the expanded approval was based on data collected in the company’s melanoma, breast cancer, and head-and-neck cancer trials. “An integrated analysis of data from all three studies showed positive diagnostic performance of Lymphoseek across the solid tumor types studied,” the firm said in announcing the new approval.
The FDA has requested a postmarketing study to be performed in pediatric cancer patients, to be completed by 2018, the firm added.
