FDA Approves Lymphoseek for Pediatric Melanoma, Rhabdomyosarcoma, and Other Solid Tumors

FDA

The FDA approved the radiopharmaceutical agent technetium Tc 99m tilmanocept injection (Lymphoseek) for accurate and precise lymph node identification in pediatric patients with melanoma, rhabdomyosarcoma, and other types of solid tumors.¹

"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, stated in a press release. "Ultimately, this may help more families to be able to get answers to some of their most concerning questions."

Lymphoseek is a radioactive diagnostic agent. A study that evaluated the agent in pediatric patients demonstrated that the radiopharmaceutical was safe and effective for those aged 1 month and older. Additionally, less than 1% of patients experienced injection site irritation and/or pain on clinical trials. No serious adverse effects were reported.

Previously, in October 2014, the regulatory agency gave the green light to expanded use of Lymphoseek as a lymphatic mapping agent for solid tumors, where it is a component of the intraoperative procedure.² Data from a combined analysis of 3 phase 3 trials supported the decision; these studies had been done in melanoma, breast cancer, and oral cavity squamous cell carcinoma.

Lymphoseek has been shown to identify lymph nodes in 97% of these patients; it has also proven to have a low false-negative rate with regard to identifying sentinel lymph nodes. Only 2.9% of patients with pathology-positive lymph nodes were not identified with the agent.

References

1. Cardinal Health Nuclear & Precision Health Solutions receives US Food and Drug Administration approval for new LYMPHOSEEK pediatric indication. News release. Cardinal Health. June 10, 2021. Accessed June 10, 2021. https://bit.ly/3pEnAUB
2. Why Lymphoseek? Cardinal Health website. Accessed June 10, 2021. https://bit.ly/355o3pn