FDA Approval for Technetium Tc 99m Tilmanocept Expanded to Include Pediatric Patients

The radiopharmaceutical diagnostic agent technetium Tc 99m tilmanocept (Lymphoseek) was granted approval by the FDA for the identification of lymph nodes in pediatric patients with melanoma, rhabdomyosarcoma (RMS), and other solid tumors, according to the company responsible for the agent, Cardinal Health.

The agent now allows for clinicians to accurately enhance lymphatic mapping and sentinel lymph node biopsy in adult and pediatric patients 1 month or older with melanoma, rhabdomyosarcoma (RMS), and other 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,” Tiffany Olson, President of Nuclear & Precision Health Solutions at Cardinal Health, said in a press release. “Ultimately, this may help more families to be able to get answers to some of their most concerning questions.”

The use of technetium Tc 99m tilmanocept for this indication is considered safe, with less than 1% of patients experiencing injection site reaction and/or pain on clinical trials. No serious adverse effects of therapy have been reported with the agent.

In a study of pediatric patients with melanoma, RMS, and other solid tumors (n = 23), lymphatic mapping was performed 15 minutes following technetium Tc 99m tilmanocept injection. The overall rate of lymph node detection, defined as at least 1 lymph node per patients, was 96%. The average number of lymph nodes detected per patient was 3. Of the 79 nodes in 21 patients who also received dye for detection, all 47 nodes identified using blue dye were also identified with technetium Tc 99m tilmanocept.

The agent is also approved for guiding sentinel lymph node biopsy in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

References

1. Cardinal Health Nuclear & Precision Health Solutions Receives U.S. Food and Drug Administration Approval for New LYMPHOSEEK Pediatric Indication. News release. Cardinal Health. June 10, 2021. Accessed June 10, 2021. https://bit.ly/35bt1Rg

2. Lymphoseek [presciribing information]. 2013. Cardinal Health. Accessed June 10, 2021. https://bit.ly/3w7WY0x