“The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.”
“The FDA has accepted a resubmitted new drug application (NDA) for Lutathera (lutetium [177Lu] oxodotreotide) for the treatment of patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Under the Prescription Drug User Fee Act, the FDA is scheduled to make a final approval decision on or before January 26, 2018.
“The NDA is based on the phase III NETTER-1 trial, which compared Lutathera with high-dose octreotide LAR for patients with grade 1 or 2 metastatic midgut NETs. In this trial, there was a 79% reduction in the risk of progression or death with Lutathera compared with octreotide.”
“Malignant neuroendocrine tumors, commonly called NETs, are easy to miss and associated with discouraging survival rates and poor quality of life. A study presented at the 2017 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) shows how a novel peptide receptor radionuclide therapy (PRRT) is significantly improving patient wellbeing.
“In the NETTER-1 Phase III Trial, a randomized prospective study, researchers focused on advanced midgut NETs and reviewed patient-reported quality of life questionnaires following treatment with lutetium-177 (177Lu)-octreotate PRRT, also known as 177Lu-DOTATATE—brand name Lutathera. Treatment with Lutathera provided some relief for neuroendocrine cancer patients in the study when compared to high-dose octreotide, used as a control.”
“Neuroendocrine cancer is exceedingly difficult to manage and unlikely to be cured, but researchers intend to slow progression of these tumors and aid survival by personalizing patient dose of peptide-receptor radionuclide therapy (PRRT), according to research presented at the 2017 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI).
“PRRT has become a treatment of choice for relatively rare and easy-to-overlook neuroendocrine tumors (NETs). The targeted treatment is designed to home in on and attach to peptide-receptor positive tumors, while sparing tissues that might otherwise be damaged by systemic treatments. However, researchers are still perfecting the practice.”
“A German multicenter study, initiated by the German Society of Nuclear Medicine, demonstrates that lutetium-177 (Lu-177)-labeled PSMA-617 is a promising new therapeutic agent for radioligand therapy (RLT) of patients with metastatic castration-resistant prostate cancer (mCRPC). The study is published in the January 2017 issue of the Journal of Nuclear Medicine and is the featured article.
“Prostate-specific membrane antigen (PSMA) is overexpressed in prostate cancer and even more so with castration-resistant disease. This makes development of new tracers for PSMA-targeted radionuclide therapies a promising treatment approach. Prostate cancer deaths are usually the result of mCRPC, and the median survival for men with mCRPC has been less than two years.”
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.”
Simone CB, Hahn SM. Clinical Cancer Research. Aug 7, 2013.
“Prostate cancer has a highly tumor-restricted prostate-specific membrane antigen (PSMA) and may be the ideal solid-organ malignancy for treatment with radioimmunotherapy. Encouraging results using lutetium-177-labeled anti-PSMA monoclonal antibody J591 from a Phase II study by Tawaga et al. support the continued clinical and preclinical development of radioimmunotherapy for solid tumors.”
Tagawa ST, Milowsky MI, Morris MJ, Vallabhajosula S, et al. Clinical Cancer Research. May 28, 2013.
“Purpose: To assess the efficacy of a single infusion of radiolabeled anti-prostate specific membrane antigen monoclonal antibody J591 (177Lu-J591) by PSA decline, measurable disease response, and survival.”