FDA Accepts Resubmission of Lutathera NDA for GEP-NETs

Excerpt:

“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.”

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Targeted Radionuclide Treatment for Neuroendocrine Tumors Improves Quality of Life

Excerpt:

“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.”

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Personalized PRRT Improves Radiation Delivery to Neuroendocrine Tumors

Excerpt:

“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 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.”

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New Therapeutic Agent Proves More Effective Treatment for Advanced Prostate Cancer

Excerpt:

“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 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.”

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Late Stage Trial Cements Lutetium Octreotate in Second-Line Setting

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.”


What's in a Label? Radioimmunotherapy for Metastatic Prostate Cancer

“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.”


Phase II Study of Lutetium-177 Labeled Anti-Prostate-Specific Membrane Antigen (PSMA) Monoclonal Antibody J591 for Metastatic Castration-Resistant Prostate Cancer

“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.”