LYMPHOSEEK Pediatric Indication Receives FDA Approval



The first radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies (SLNB) has been approved for pediatric use by the US Food and Drug Administration (FDA). LYMPHOSEEK (technetium Tc 99m tilmanocept) injection from Cardinal Health will provide accurate and precise lymph node identification in pediatric patients one month and older with melanoma, rhabdomyosarcoma (RMS) or other types of solid tumors

“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 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 year1.

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 old2.

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.

[1] Strouse JJ, Fears TR, Tucker MA, et al. Pediatric melanoma: risk factor and survival analysis of the surveillance, Epidemiology and End Results database. J Clin Oncol. 2005; 23:4735–41. [PubMed] [Google Scholar]
[2] American Cancer Society. Cancer Facts & Figures 2020. Atlanta, Ga: American Cancer Society; 2020.

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LYMPHOSEEK Pediatric Indication Receives FDA Approval.  Appl Rad Oncol. 

June 11, 2021

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