FDA Approves Radiopharmaceutical Diagnostic Agent for Pediatric Patients

The FDA approved injectable technetium Tc 99m tilmanocept (Lymphoseek), a radiopharmaceutical agent that targets lymphatic mapping and guiding for sentinel lymph node biopsies (SLNB), for use in pediatric patients with melanoma, rhabdomyosarcoma, and other solid tumors, according to Cardinal Health, the manufacturer of the product.

"This new indication opens the door for physicians, oncologists and nuclear medicine specialists to more accurately stage the spread of disease using lymphatic mapping in pediatric cancer patients," said Tiffany Olson, President of Nuclear & Precision Health Solutions at Cardinal Health, in a statement. "Ultimately, this may help more families to be able to get answers to some of their most concerning questions."

A clinical trial showed that the diagnostic agent technetium Tc 99m tilmanocept is safe and effective in patients 1 month and older. Less than 1% of patients experienced injection site irritation and/or pain in the trials, and there were no serious adverse events reported.

Technetium Tc 99m tilmanocept can be used with or without scintigraphic imaging to achieve lymphatic mapping with a handheld gamma counter that locates lymph nodes that re draining to a primary tumor site in adult and pediatric patients with solid tumors or the guiding of sentinel lymph node biopsies with a handheld gamma counter in patients with clinically node-negative squamous cell carcinoma of the oral cavity, breast cancer, or melanoma.

Reference

Cardinal Health. Cardinal Health™ Nuclear & Precision Health Solutions Receives U.S. Food and Drug Administration Approval for New LYMPHOSEEK® Pediatric Indication. Published June 10, 2021. https://ir.cardinalhealth.com/news/press-release-details/2021/Cardinal-Health-Nuclear--Precision-Health-Solutions-Receives-U.S.-Food-and-Drug-Administration-Approval-for-New-LYMPHOSEEK-Pediatric-Indication/default.aspx