The US Food and Drug Administration has approved Johnson & Johnson’s drug delivery system for a type of bladder cancer, offering a potential surgery-free option for patients.
Reuters reports that the drug release system, branded as Inlexzo, was given the green light for patients with a type of high-risk non-muscle invasive bladder cancer who did not respond to treatment with Bacillus Calmette-Guerin therapy, the current standard-of-care, and who are ineligible for, or refuse to undergo, bladder removal surgery.
The approval was based on data from a mid-stage study in which more than 82% of the patients who received Inlexzo showed no signs of cancer, and more than half of them remained cancer-free for at least a year.
“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.
Inlexzo is inserted directly into the bladder where it remains for three weeks per treatment cycle for up to 14 cycles. It does not interfere with daily activities and provides a sustained release of the chemotherapy drug gemcitabine into the bladder.
Most common side effects associated with the treatment include urinary frequency, urinary tract infection and pain, said J&J, which acquired the drug when it bought private biotech TARIS Biomedical in 2019.
The drug is also being tested in patients with muscle-invasive bladder cancer.
Reuters article – US FDA approves J&J's bladder cancer treatment (Open access)
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