The US Food and Drug Administration (FDA) has granted regulatory approval to Novartis (NYSE: NVS) for its radioligand therapy (RLT) Lutathera (lutetium Lu 177 dotatate) for the treatment of SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in patients aged 12 and older. This expansion of the drug’s original indication for adult patients marks Lutathera as the first therapy approved for this rare cancer in a pediatric setting.
The FDA’s decision was supported by a Phase II trial that demonstrated a safety profile and an estimated radiation absorbed dose consistent with previous observations in adult patients.
According to the Swiss pharmaceutical giant, Lutathera is also available in Europe and Japan, indicating its global reach in treating this specific type of cancer.- Flcube.com
