The U.S. Food and Drug Administration has approved Johnson & Johnson’s (JNJ.N), opens new tab drug delivery system for patients with a type of bladder cancer, the drugmaker said on Tuesday, offering a potential alternative to surgically remove the organ.<\/p>\n
The drug release system, branded as Inlexzo, was approved for patients with a type of high-risk non-muscle invasive bladder cancer who did not respond to treatment with Bacillus Calmette-Guerin (BCG) therapy, the current standard-of-care, and are ineligible for, or refuse to undergo bladder removal surgery.<\/p>\n
About 75% of bladder cancer cases are non-muscle-invasive at the time of diagnosis, according to government data.<\/p>\n
The approval was based on data from a mid-stage study, in which more than 82% of the patients showed no signs of cancer after three months and over half of them remained cancer-free at least for a year after the treatment with Inlexzo.<\/p>\n
“This drug, at ultra low doses for long periods of time… behaves in a way that not only pushes the disease into remission, but then maintains it through some immune memory,” Christopher Cutie, vice president and disease area leader for bladder cancer, at J&J, told Reuters ahead of the FDA decision.<\/p>\n
Inlexzo, also known as TAR-200, is inserted directly into the bladder where it remains for three weeks per treatment cycle for up to 14 cycles, the company said.<\/p>\n
It does not interfere with daily activities and provides sustained release of chemotherapy drug, gemcitabine, into the bladder.<\/p>\n
Most common side-effects associated with the treatment include urinary frequency, urinary tract infection and pain or burning sensation during urination, J&J said.<\/p>\n
The drug is also being tested in patients with muscle-invasive bladder cancer.
\nLast year, J&J had discontinued a late-stage study testing TAR-200 in some patients with muscle-invasive bladder cancer after it failed to show superior benefits compared to chemoradiation.<\/p>\n","protected":false},"excerpt":{"rendered":"
The U.S. Food and Drug Administration has approved Johnson & Johnson’s (JNJ.N), opens new tab drug delivery system for patients with a type of bladder cancer, the drugmaker said on Tuesday, offering a potential alternative to surgically remove the organ. The drug release system, branded as Inlexzo, was approved for patients with a type of […]<\/p>\n","protected":false},"author":2,"featured_media":1792,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[40],"tags":[486],"class_list":{"0":"post-1791","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-sitefansalaran-food-and-drug","8":"tag-us-fda-approves-jjs-bladder-cancer-treatment"},"yoast_head":"\n