“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.”
“Seasonal influenza vaccination resulted in increased risk of immune-related adverse events (AEs) in lung cancer patients treated with PD-1/PD-L1 checkpoint inhibitors in a small study. However, the risks of the flu itself may still outweigh the risks associated with vaccination.
” ‘Use of immune checkpoint inhibitors is now standard clinical practice for many oncology patients, and these same patients—particularly those with lung cancer—also face increased risk for complications from influenza,’ said Sacha Rothschild, MD, PhD, of University Hospital Basel in Switzerland, in a press release. ‘Although routine influenza vaccination has long been recommended for cancer patients, there are concerns that it might trigger an exaggerated immune response in this subgroup receiving checkpoint inhibitors.’ ”
“Treatment advances for patients with neuroendocrine tumors (NETs) are bringing hope to a therapeutic landscape that has seen little activity until recent years, says Jonathan Strosberg, MD.
“In an interview with OncLive, Strosberg, medical oncologist, Department of Gastrointestinal Oncology, section head, Neuroendocrine Division, chair, Gastrointestinal Department Research Program, Moffitt Cancer Center, discussed recent developments and emerging agents in the field of NETs.”
“Johns Hopkins Kimmel Cancer Center scientists report data from a new study providing evidence that random, unpredictable DNA copying ‘mistakes’ account for nearly two-thirds of the mutations that cause cancer. Their research is grounded on a novel mathematical model based on DNA sequencing and epidemiologic data from around the world.
” ‘It is well-known that we must avoid environmental factors such as smoking to decrease our risk of getting cancer. But it is not as well-known that each time a normal cell divides and copies its DNA to produce two new cells, it makes multiple mistakes,’ says Cristian Tomasetti, Ph.D., assistant professor of biostatistics at the Johns Hopkins Kimmel Cancer Center and the Johns Hopkins Bloomberg School of Public Health. ‘These copying mistakes are a potent source of cancer mutations that historically have been scientifically undervalued, and this new work provides the first estimate of the fraction of mutations caused by these mistakes.’ ”
“Many of the nation’s leading research organizations and cancer centers have voiced their opposition to President Donald Trump’s proposed budget, which includes a $5.8 billion cut to NIH funding in 2018.
“The budget ‘blueprint’ — released Thursday — proposes $54 billion in cuts overall, including a 16.2% decrease, or $12.6 billion, for the Department of Health and Human Services.”
“ASCO President Daniel F. Hayes, MD, FACP, FASCO, released the following statement today:
” ‘We soundly oppose President Trump’s budget outline, which would cut $6 billion from the National Institutes of Health (NIH). Reducing NIH’s funding by nearly 20% will devastate our nation’s already-fragile federal research infrastructure and undercut a longstanding commitment to biomedical science that has fueled advances in cancer prevention, diagnosis, and treatment.
” ‘When we are on the cusp of tremendous advances in cancer care, the United States can’t turn back the clock on research that will benefit millions of Americans with life-threatening diseases and their families. Gutting the U.S. research infrastructure won’t make America First, but will decidedly place the United States behind other countries in scientific advances. Failure to nurture the historic U.S. investment in research places health outcomes, scientific leadership, and economic growth at risk.’ ”
“On behalf of the entire cancer research community, the American Association for Cancer Research (AACR) was shocked to learn that the Trump administration is proposing to cut $5.8 billion from the National Institutes of Health (NIH) budget in fiscal year (FY) 2018. At a time when extraordinary progress is being made against cancer and many other diseases, these draconian cuts would set research back for decades and also threaten the careers of an entire generation of young investigators working in labs and clinics all over the country who are committed to improving public health and saving lives.”