Thursday, May 19, 2016
The U.S. Food and Drug Administration approved Roche Holding AG’s Tecentriq for advanced bladder cancer, which uses the body’s immune system to fight the disease.
The FDA said Tecentriq—also known as atezolizumab—is the first product in its class to get U.S. regulatory approval to treat advanced cases of a common type of bladder cancer called urothelial carcinoma. The treatment will cost about $12,500 a patient a month.
The FDA also approved a diagnostic to determine which patients may be most responsive to treatment with Tecentriq from Ventana Medical Systems Inc., which is part of Roche Group.
Roche’s Genentech unit developed Tecentriq, which shrank tumors in patients in a clinical study.
Tecentriq, which is infused intravenously, targets certain proteins that help cancer cells escape destruction by the body’s immune system. Blocking such proteins can help the immune system fight the cancer.
The National Cancer Institute estimates there will be 76,960 new cases of bladder cancer and 16,390 deaths from the disease in 2016, according to the FDA.
The FDA designated atezolizumab as a “breakthrough therapy” for treatment of bladder cancer, a status the agency reserves for drugs that show promise for serious diseases. The FDA also granted priority review status and accelerated approval status for Tecentriq, designations that aim to get drugs for serious conditions to market more quickly.
Source : wsj.com
