“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.”
“With the arrival of two revolutionary treatment strategies, immunotherapy and personalized medicine, cancer researchers have found new hope — and a problem that is perhaps unprecedented in medical research.
“There are too many experimental cancer drugs in too many clinical trials, and not enough patients to test them on.
“The logjam is caused partly by companies hoping to rush profitable new cancer drugs to market, and partly by the nature of these therapies, which can be spectacularly effective but only in select patients.”
“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.”
“The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.
” ‘Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,’ said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs. ‘We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult a health care professional about proper prevention, diagnosis and treatment of cancer.’ ”
“You’ve probably heard about powerful new cancer medicines like Keytruda and Opdivo. As advertisedon TV, these drugs release brakes on the immune system to make tumors disappear and extend survival in deadly diseases like lung cancer and melanoma. But these agents, called checkpoint inhibitors, work in only a fraction of patients. Scientists are searching for diagnostic tests to predict who will be helped, and who won’t.
“A promising solution comes from Foundation Medicine, a molecular diagnostics company headquartered in Cambridge, Mass. Foundation offers a cancer genome profiling test that evaluates mutations in DNA. With results from its standard FoundationOne panel, Foundation calculates a Tumor Mutation Burden (TMB) score. This quantitative readout―based on the number and type of DNA changes per megabase, a length of DNA―may prove helpful to patients considering immune treatment for many advanced forms of cancer.”
“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.’ ”