FDA Approves Cardinal Health’s Radiopharmaceutical Agent for Pediatric Lymph Node Biopsies
Cardinal Health’s Lymphoseek injection has received FDA approval for targeted lymphatic mapping and guiding sentinel lymph node biopsies (SLNB) in pediatric patients.
The agent, technetium Tc 99m tilmanocept, which was already approved for use in adults, can now be used to identify lymph nodes in pediatric patients with melanoma and other types of solid tumors.
According to the company, a clinical study evaluating Lymphoseek in pediatric patients demonstrated the agent is safe and effective in patients one month and older. Less than one percent of patients experienced injection site irritation and/or pain in clinical trials, and no serious adverse reactions were seen.