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Cardinal Health receives FDA approval for new LYMPHOSEEK pediatric indication

Press releases may be edited for formatting or style | June 10, 2021 Molecular Imaging Pediatrics
DUBLIN, Ohio, June 10, 2021 /PRNewswire/ -- Cardinal Health (NYSE: CAH) today announced that LYMPHOSEEK® (technetium Tc 99m tilmanocept) injection – the first and only radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies (SLNB) – 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. "Ultimately, this may help more families to be able to get answers to some of their most concerning questions."

In addition to adult use, this new indication will provide accurate and precise lymph node identification in pediatric patients with melanoma, rhabdomyosarcoma (RMS) or 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 SLNB in pediatric melanoma cases, the most common skin cancer in children, which results in around 500 new cases per year [1].

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Approximately the same number of pediatric cases of RMS, a rare type of cancer that forms in soft tissues, such as eyes, occurs each year in the United States. RMS is most often diagnosed in children and teens, with more than half of diagnoses in children younger than 10 years old [2].

LYMPHOSEEK® is a radioactive diagnostic agent. A clinical study to evaluate LYMPHOSEEK® in pediatric patients has shown that the radiopharmaceutical is safe and effective for patients one month and older. Less than one percent of patients reported injection site irritation and/or pain in clinical trials, with no serious adverse reactions to the drug being reported.

With the largest national pharmacy network and the industry's most comprehensive portfolio of radiopharmaceuticals – with best-in-class service, accuracy and reliability to deliver on-demand prescriptions across the country – Cardinal Health™ Nuclear & Precision Health Solutions is helping shape the future of precision healthcare.


About Cardinal Health
Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities. With 50 years in business, operations in more than 40 countries and approximately 48,000 employees globally, Cardinal Health is essential to care.


About Nuclear & Precision Health Solutions:
Cardinal Health™ Nuclear & Precision Health Solutions develops, manufactures, prepares, dispenses and delivers over 12 million time-critical, patient-specific radiopharmaceutical doses annually via a U.S. network of more than 130 nuclear pharmacies and more than 30 PET sites and other manufacturing facilities.


SOURCE Cardinal Health

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