The approval of Lutathera for pediatric patients is based on the NETTER-P trial, which demonstrated a safety profile consistent with adult patients and an estimated radiation absorbed dose within established organ thresholds. Lutathera is a targeted therapy that binds to SSTRs, which are commonly expressed on GEP-NETs, and delivers a therapeutic dose of radiation directly to the tumor cells.
This approval marks a significant milestone in the treatment of pediatric GEP-NETs, as these tumors are often difficult to diagnose and treat. The availability of Lutathera provides a new therapeutic option for these young patients, offering hope for improved outcomes and a better quality of life.
In addition to the US approval, Lutathera is also approved in Europe for SSTR-positive GEP-NETs in adults and in Japan for SSTR-positive NETs. The approval of Lutathera for pediatric patients further expands its global reach and underscores Novartis’ commitment to developing innovative therapies for patients with rare and complex diseases.
