NEW YORK – The US Food and Drug Administration on Tuesday approved Novartis' radioligand therapy Lutathera (lutetium Lu 177 dotatate) as a treatment for pediatric patients with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
The treatment was approved in the US in 2018 for adult patients with SSTR-positive GEP-NETs. The latest approval makes the drug available to patients 12 and older including those with foregut, midgut, and hindgut NETs.
The FDA approved the treatment after reviewing the results of the Phase II NETTER-P trial, in which Lutathera was comparably safe and had similar drug exposure in the pediatric and adult patient setting.