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Neuroendocrine tumor (NETs) is a rare type of tumor that can develop in the gastrointestinal tract, pancreas, lungs and many other organs of neuroendocrine cells.
recently, the FDA announced that it had approved Lutathera (Lutetium Lu 177 dotatate) of Novart Group Inc.'s Advanced Accelerator Applications to treat gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs) that are positive for growth inhibitor.about Luthera
Lutathera is a radioactive drug that binds to growth inhibitor inhibitor on the surface of tumor cells and enters the cells, causing damage to tumor cells through radioactivity.
previously, Lutathera had been eligible for FDA orphan drugs and had been eligible for priority review.study
Lutathera's efficacy was validated in two key Phase 3 clinical trials.
in the first trial, combined with the best standard care (30mg octreotide LA every four weeks), Lutathera showed good results, reducing the risk of disease progress or death by 79% (HR 0.21, 95% CI:0.13-0.) 32< p<0.001);
In the second trial, Lutathera had 16 percent of the 1,214 tumor patients who were positive for growth-inhibitor-positive tumors in a sub-group of 360 GEP-NETs patients.
second clinical trial is part of the FDA's expanded use program, which allows patients with serious and life-threatening diseases to access new drugs for treatment.
