“Advanced Accelerator Applications S.A…, an international specialist in Molecular Nuclear Medicine (MNM), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for Lutathera, a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of gastro entero pancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. The Prescription Drug User Fee Act (PDUFA) target action date is December 28, 2016.
“Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.”
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Neuroendocrine tumors of the digestive system (GI-NETs) can arise in different parts of the digestive tract. GI-NETs originating in the ileum, duodenum, and appendix are known as midgut NETs, and tumors of the stomach, colon, and rectum are non-midgut NETs. Many of these tumors are functional; that is, they produce a variety of hormonal substances that cause serious, debilitating symptoms. Continue reading…
With updated data further proving its efficacy, Jonathan R. Strosberg, MD, says Lu-Dotatate 177 could be an excellent addition to oncologists’ armamentarium against midgut neuroendocrine tumors (NETs).
“The randomized phase III NETTER-1 trial examined the efficacy of the peptide receptor radionuclide therapy (PRRT) Lu-Dotatate as a treatment for patients with midgut NETs, specifically in the small intestine and proximal colon.
“The trial recruited 229 patients with inoperable, somatostatin receptor-positive NETs. All patients had progressed on standard-dose somatostatin analog therapy and were evenly randomized to either 4 administrations of 7.4 gigabecquerel of Lu-Dotatate every 8 weeks, or a control arm receiving high-dose octreotide LAR of 60 mg every 4 weeks.”
“The radiopharmaceutical Lu-Dotatate (177Lutetium DOTATATE; Lutathera) demonstrated an unprecedented 79% reduction in the risk of progression or death compared with high-dose octreotide LAR (60 mg) in patients with progressive, metastatic midgut neuroendocrine tumors (NETs), according to results from NETTER-1 trial presented by Jonathan Strosberg, MD, at the 2015 NANETS Symposium.”
” ‘The findings were, in my opinion, extraordinarily impressive, the median progression-free survival improved by nearly 80%, which is fairly unprecedented in oncologic studies,’ said Strosberg, a medical oncologist and researcher at the Moffitt Cancer Center. ‘The finding is important because limited therapeutic options exist for such patients, who comprise 20% to 45% of neuroendocrine tumor cases.’ ”
“The NETTER-1 trial is the first prospective, randomized, phase III study for patients with midgut NETs, specifically those in the ileum and cecum. Patients in the trial had progressed on prior therapy with octreotide at 30 mg and had inoperable, somatostatin receptor positive tumors.”
“Vienna, Austria: Patients with advanced gastrointestinal neuroendocrine tumours (NETs) have limited treatment options and there are few oncologists who are specialised in this relatively rare disease. But now results from a multi-centre randomised international trial of an innovative treatment show a marked improvement in the length of time patients with mid-gut NETs live without the disease getting worse (progression-free survival, or PFS), researchers will report to the 2015 European Cancer Congress today.
“Professor Philippe Ruszniewski, MD, Head of the Department of Gastroenterology-Pancreatology, Beaujon Hospital, Clichy, France, who is also a Professor at Paris Diderot University, will tell the Congress that results of the NETTER-1 phase III trial of 177Lu-DOTATATE (Lutathera) show a PFS that has never been shown before in this type of cancer. “Because these patients have a real unmet medical need, this is particularly pleasing for us,” he says.
“Lutathera is a member of the family of novel treatments called Peptide Receptor Radionuclide Therapy (PRRTs) which involve targeting tumours with radiolabelled somatostatin analogue (SSA) peptides. The technique belongs to the larger family of molecular nuclear medicine, where trace amounts of active substances, or radiopharmaceuticals, are used to create images and to treat various diseases including cancer. SSAs are widely used in gastrointestinal NETs cancer to reduce symptoms such as diarrhoea.”