RARITAN, N.J.– Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved INLEXZO™ (gemcitabine intravesical system), the first and only drug-releasing system to provide extended local delivery of a cancer therapy directly into the bladder. The approval represents a major advance for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), a group with limited treatment options short of bladder removal surgery.
INLEXZO™, previously known as TAR-200, is indicated for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The device remains in the bladder for three weeks per treatment cycle for up to 14 cycles, inserted by a healthcare professional in a quick outpatient procedure without general anesthesia.
“When we acquired this novel therapy in 2019, our ambition was to give patients with bladder cancer a renewed sense of hope and belief,” said Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine at Johnson & Johnson. “In an area that has seen little progress for more than 40 years, INLEXZO delivers a first-of-its-kind breakthrough innovation with a bright future ahead.”
Approval was based on data from the Phase 2b SunRISe-1 trial (NCT04640623), which showed that 82 percent of patients achieved a complete response, with 51 percent maintaining that response for at least one year. The therapy was generally well tolerated, with the most common side effects including urinary frequency, infection, urgency, and mild laboratory abnormalities.
“I see many patients that ultimately become BCG-unresponsive and often face life-altering bladder removal. These patients now may be ideal candidates for newly approved INLEXZO,” said Sia Daneshmand, M.D., principal investigator of the SunRISe-1 trial and Professor of Urology at the Keck School of Medicine of the University of Southern California. “In my experience, INLEXZO is well tolerated and delivers clinically meaningful results. This will change the way we treat appropriate patients that haven’t responded to traditional therapy.”
John Reed, M.D., Ph.D., Executive Vice President, R&D, Innovative Medicine at Johnson & Johnson, added: “INLEXZO is a novel therapy with powerful efficacy and a demonstrated safety profile. As the only major healthcare company that hosts both pharmaceuticals and medical devices, we leveraged the speed and scale of Johnson & Johnson to accelerate innovation and deliver this important therapy to patients.”
Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network (BCAN), called the approval a milestone for the community: “This approval represents the kind of progress that brings new options to a community that urgently needs them. Patients with bladder cancer need guidance and collaboration with providers to navigate bladder-sparing treatment options, including newly approved treatments like INLEXZO.”
The FDA granted INLEXZO Breakthrough Therapy Designation, Real-Time Oncology Review, and Priority Review. Johnson & Johnson said its patient support program, J&J withMe, will offer cost support, educational resources, and dedicated care navigation at no cost to patients once the treatment is prescribed.
