The Lymphoseek (technetium Tc 99m tilmanocept) injection—a radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies—has been approved for pediatric use by the U.S. Food and Drug Administration (FDA).
"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 addition to adult use, this new indication will provide accurate and precise lymph node identification in pediatric patients with melanoma, rhabdomyosarcoma, and other types of solid tumors. This will offer physicians, oncologists, and nuclear medicine specialists an efficient, accurate, and safe option to enhance lymphatic mapping and sentinel lymph node biopsies in pediatric patients with cancer.
Lymphoseek is a radioactive diagnostic agent. A clinical study to evaluate the radiopharmaceutical in pediatric patients has shown that the radiopharmaceutical is safe and effective for patients aged 1 month and older. Less than 1% of patients reported injection site irritation and/or pain in clinical trials, with no serious adverse reactions to the drug being reported.
