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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.

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 therapy, the current standard-of-care, and are ineligible for, or refuse to undergo bladder removal surgery.

“We believe Inlexzo represents a unique bladder-sparing treatment that addresses a significant unmet need for patients who have limited options after unsuccessful BCG therapy,” said Guggenheim analyst Vamil Divan.

Divan estimates potential revenue of about $3.4 billion for Inlexzo by 2040.

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 over 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 ahead of the FDA decision.

Inlexzo 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 a 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, J&J said.

J&J 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.