The U.S. Food and Drug Administration (FDA) has approved Novartis’ Lutathera (lutetium Lu 177 dotatate) for children 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The Swiss pharma said the approval marks the first for a medicine for children with this type of rare cancer.
The approval was based on results from the NETTER-P trial in patients 12 to less than 18 years old with SSTR+ GEP-NETs. The study’s safety profile was similar to that seen in the adult NETTER-1 trial. Also, the estimated radiation absorbed dose in children was within established organ thresholds for external beam radiation.
According to Novartis (NVS), “NETs are a type of cancer that originates in neuroendocrine cells throughout the body and are commonly considered slow-growing malignancies.”
