The Food and Drug Administration (FDA) has approved Lymphoseek® (technetium Tc 99m tilmanocept) injection for lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in pediatric patients 1 month of age and older with solid tumors requiring this The procedure is part of the intraoperative treatment. Previously, the radioactive diagnostic agent was only approved for adults 18 years of age and older.
The approval was based on data from an open-label, multicenter, single-arm phase 2 study (ClinicalTrials.gov Identifier: NCT02509598) that assessed the efficacy and safety of Lymphoseek in pediatric patients with melanoma, rhabdomyosarcoma (RMS), or other solid tumors. Of the 23 patients receiving Lymphoseek, 5 (22%) had melanoma, 4 (17%) had RMS, 12 (52%) had non-RMS soft tissue sarcomas, and 2 (9%) had atypical spitz nevi. The mean age of the patients was 11.6 years (range 1.7-17 years) and 65% were female.
The results showed an overall lymph node detection rate (defined as at least 1 lymph node detected) of 96% (22/23). The mean number of lymph nodes detected was approximately 3 per patient. No differences in safety were identified between pediatric patients and elderly patients; the most common side effects reported with Lymphoseek were injection site irritation and/or pain.
“This new indication opens the door for physicians, oncologists and nuclear medicine specialists to more accurately map 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 could help more families get answers to some of their most troubling questions.”
Lymphoseek is available as a kit containing 5 multi-dose vials; each vial consists of 250 mcg of tilmanocept powder.
Cardinal Health™ Nuclear & Precision Health Solutions receives approval from the US Food and Drug Administration for new Lymphoseek® pediatric indication. [press release]. Dublin, Ohio: Cardinal Health; June 10, 2021.Lymphoseek® [package insert]. Dublin, Ohio: Cardinal Health; 2021.
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