Sept 9 (Reuters) - The U.S. Food and Drug Administration

has approved Johnson & Johnson's ( JNJ ) 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 months and over half of them remained cancer-free at

least for a year after the treatment with Inlexzo.

"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.

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.

It does not interfere with daily activities and provides

sustained release of chemotherapy drug, gemcitabine, into the

bladder.

Most common side-effects associated with the treatment

include urinary frequency, urinary tract infection and pain or

burning sensation during urination, J&J said.

The drug is also being tested in patients with

muscle-invasive bladder cancer.

Last 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.