(Reuters) -The U.S. Food and Drug Administration has approved Johnson & Johnson’s 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 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.
About 75% of bladder cancer cases are non-muscle-invasive at the time of diagnosis, according to government data.
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