Cardinal Health (NYSE:CAH) announced today that the FDA approved its Lymphoseek injection for pediatric use.
Dublin, Ohio-based Cardinal Health touts Lymphoseek, which it acquired from Navidea Biopharmaceuticals (NYSE:NAVB) in November 2016, as the first and only radiopharmaceutical agent specifically designed for targeted lymphatic mapping nad guiding sentinel lymph node biopsies (SLNB).
The new indication will expand upon the already approved adult use of Lymphoseek to allow lymph node identification in pediatric patients with melanoma, rhabdomyosarcoma (RMS) or other types of solid tumors, according to a news release.
Lymphoseek has shown in clinical trials to be safe and effective for patients one month and older, with less than 1% of patients reporting injection site irritation and/or pain in those trials, with no serious adverse reactions to the drug reported, Cardinal Health said.
“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,” Cardinal Health president of nuclear & precision health solutions Tiffany Olson said in the release. “Ultimately, this may help more families to be able to get answers to some of their most concerning questions.”