Johnson & Johnson’s bladder cancer treatment inlexzo receives FDA approval

RARITAN, N.J. - Johnson & Johnson (NYSE:JNJ) announced Tuesday that the U.S. Food and Drug Administration has approved INLEXZO (gemcitabine intravesical system) for treating adults with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.

The treatment represents the first and only intravesical drug releasing system that provides extended local delivery of a cancer medication into the bladder. INLEXZO is designed to remain in the bladder for three weeks per treatment cycle for up to 14 cycles.

In the SunRISe-1 clinical study supporting the approval, 82 percent of patients achieved complete response, meaning no signs of cancer were found after treatment. Of those responding patients, 51 percent maintained a complete response for at least one year.

The FDA granted INLEXZO Breakthrough Therapy Designation, Real-Time Oncology Review, and Priority Review designations.

"In an area that has seen little progress for more than 40 years, INLEXZO delivers a first-of-its-kind breakthrough innovation," said Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson, in a statement based on the press release.

The most common adverse reactions reported in the clinical trial included urinary frequency, urinary tract infection, dysuria, and micturition urgency.

The treatment is specifically designed for patients seeking bladder preservation who have limited options after unsuccessful BCG therapy and for those refusing or ineligible for bladder removal surgery. Healthcare professionals can place INLEXZO in an outpatient setting in a few minutes, without requiring general anesthesia.

Johnson & Johnson stated it will provide patient support through its J&J withMe program, offering cost support and educational resources for patients prescribed the treatment.

In other recent news, Johnson & Johnson reported strong financial results for the second quarter of 2025, with worldwide sales reaching $23.7 billion, representing a 4.6% operational sales growth. The company also increased its full-year sales guidance to $92.9 billion and adjusted its earnings per share guidance to $10.85. In a strategic move, Johnson & Johnson announced a $2 billion investment to expand its manufacturing presence in North Carolina, which includes a new facility at FUJIFILM’s biopharmaceutical site in Holly Springs. This investment is expected to create approximately 120 new jobs over the next decade. Wolfe Research recently raised its price target for Johnson & Johnson to $195 from $175, maintaining an Outperform rating due to confidence in the company’s upcoming talc litigation outcome. Additionally, Johnson & Johnson appointed John Morikis, former CEO of Sherwin-Williams, to its Board of Directors. Morikis brings extensive experience from his tenure at Sherwin-Williams, where he oversaw significant company growth. These developments reflect Johnson & Johnson’s ongoing efforts to strengthen its market position and operational capabilities.

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