The National Institute for Health and Care Excellence (NICE), has approved everolimus (brand name Afinitor, manufactured by Novartis) for routine use as a regular National Health Service (NHS) treatment option for patients with advanced renal cell carcinoma (RCC). NICE provides evidence-based guidelines on health care for the NHS and other medical organizations in England.
Previously, the drug was available only to NHS patients if they applied through the Cancer Drugs Fund (CDF). However, NICE reappraised the drug and assessed the cost and clinical effectiveness. As part of the reappraisal, Novartis Pharmaceuticals submitted a further discount to the cost of everolimus.
The US Food and Drug Administration (FDA) has approved a new filter from Nephros (River Edge, NJ).
In early March 2017, Nephros received 510(k) clearance to market its EndoPur™ Endotoxin 10-Inch Filter.
The filter is designed to provide hemodialysis-quality water to dialysis machines. It fits into existing filter cartridge housings of the reverse osmosis (RO) water systems that provide dialysis clinics with high volumes of ultrapure water. The EndoPur™ has an endotoxin barrier with the smallest pore size on the market, the company announced.
“With the FDA clearance of the EndoPur, we have achieved a significant milestone in the expansion
After a rejection last year by the U.S. Food and Drug Administration (FDA) and the need for a complete response letter explaining data, Amgen (Thousand Oaks, CA) now has gained FDA approval for its drug Parsabiv. Approved in early February, the drug treats secondary hyperparathyroidism (secondary HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Parsabiv is the first therapy approved for this condition in 12 years and the only calcimimetic drug that can be administered intravenously by the dialysis health care team three times a week at the end of the hemodialysis session, Amgen stated.
Drug combinations against advanced kidney cancer are the new focus in research and treatment, say many oncology experts. One combination in the news is nivolumab and ipilimumab, each an immunotherapy drug. The first approved (2016) combination for advanced kidney cancer is everolimus plus lenvatinib.
Other combinations, which include some of the aforementioned drugs, are also being tested, in a new era that medical oncologist James Hsieh is calling the Golden Era for advances against kidney cancer.
The types of treatments that are being combined use the properties of vascular endothelial growth factor (VEGF) in drugs that shut down blood supply
More control over vascular access in dialysis can be an important part of dialysis self-care.
In addition to dialysis centers training patients to handle their own vascular access when motivated to learn, a new maker of venous access, Advent Access (Singapore), is positioning itself as a “disruptive” new technology that will further help patients on dialysis.
Advent Access’s “device-guided blunt access” proprietary platform aims to preserve AV fistula health and potentially allow hemodialysis centers to treat a larger patient population with fewer nurses or other support. The company’s subcutaneous access device is placed adjacent—but noninvasive— to an AV fistula.
Eisai (Tokyo), a maker of cancer and neurological therapies, is closer to gaining a proven new benefit for its renal cancer treatment, lenvatinib (Kisplyx), in Germany, where 15,000 people develop renal cell carcinoma (RCC) every year.
The German Institute for Quality and Efficiency in Health Care (IQWiG) published conclusions that lenvatinib when delivered in combination with everolimus has additional benefits in patients with RCC. The results of the institute’s report were announced by Eisai on Jan. 4, 2017, and will be evaluated by Germany’s Federal Joint Committee. A final decision on whether to accept results from the IQWiG report is
Recent news of a new kidney cancer treatment in early studies and insight into when to use alpha blockers to treat kidney stones top recent industry developments.
A new kidney cancer investigational medication has had good results in a phase 1 study. The compound CB-839, developed by Calithera Biosciences in South San Francisco, targets glutaminase, an enzyme involved in the conversion of glutamine to glutamate, a nutrient that cancer cells need to survive, the researchers noted. “Glutaminase is a very interesting target, and previous work in the lab has shown that CB-839 is effective at inhibiting it in renal cell
Amgen’s drug etelcalcetide (Parsabiv™) has been approved for marketing in Europe, through a decision by the European Commission announced in November 2016. Applications are also pending in the United States and Japan for etelcalcetide, which treats secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) who are on hemodialysis. In Europe, the prevalence of SHPT within dialysis populations ranges from 30% to 49%, Medscape reports. The EC approval covers 28 countries in the EU; Norway, Iceland, Liechtenstein, and members of the European Economic Area (EEA), can take corresponding decisions based on the EC decision.
The world’s largest provider of dialysis services now has a new business: a regenerative medicine company. Frensenius Medical Care (Bad Homburg, Germany) has opened the doors of Unicyte AG, a subsidiary that will undertake research into kidney and liver diseases, diabetes, and cancer.
Fresenius’ primary partner in Unicyte is the Molecular Biology Center at the University of Turin in Italy. The center specifically focuses on the study of the molecular mechanisms underlying the physiopathological processes that result in cardiovascular diseases, inflammation, and cancer, as well as on the intricacies of stem cell biology. The research efforts are aimed at developing
Acombination therapy called Byvalson has been approved by the FDA to treat high blood pressure.
Taken together once a day in a fixed dose pill from Allergan (Parsippany, NJ; Dublin, Ireland), the two drugs—Nebivolol and Valsartan—work by using different mechanisms to lower blood pressure.
Nebivolol (marketed in the US as Bystolic) is a beta-adrenergic receptor blocking agent. While the drug’s mechanism of action “has not been definitively established,” the company suggested that its actions might include vasodilation and decreased peripheral vascular resistance (PVR), reduced heart rate, and myocardial contractility and renin suppression.
Valsartan (brand name Diovan) is an angiotensin II