FDA approves Lutathera® for 12-17 pediatric GEP-NET patients based on NETTER-P trial results.
Novartis' Lutathera®, a radioligand therapy, has been approved by the FDA as the first medicine specifically for pediatric patients aged 12-17 with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The approval is based on the NETTER-P trial, which demonstrated consistent safety and comparable drug exposure between pediatric and adult patients. GEP-NETs, a rare cancer, are often unresectable and commonly diagnosed in late stages.
April 23, 2024
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