Patients eligible for the therapy will be aged 12 years and older and have somatostatin receptor (SSTR)-positive gastroenteropancreatic NETs, including foregut, midgut and hindgut NETs.
The FDA’s decision was supported by positive results from the NETTER-P trial, which evaluated Lutathera in patients aged 12 to less than 18 years with SSTR-positive GEP-NETs.
The study demonstrated a safety profile consistent with the adult population studied in NETTER-1, the pivotal trial for approval of Lutathera in adults, and showed that the estimated radiation-absorbed dose in paediatric patients was within established organ thresholds for external beam radiation and comparable to that in adults for the approved dose.
