Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved INLEXZO (gemcitabine intravesical system), a novel treatment for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. This approval marks a significant advancement for patients who have limited treatment options following unsuccessful BCG therapy and for those unwilling or unable to undergo bladder removal surgery.
INLEXZO is the first and only intravesical drug-releasing system designed to deliver cancer medication directly and continuously into the bladder over three weeks per treatment cycle, up to 14 cycles. The therapy is administered via a simple outpatient procedure using a co-packaged urinary catheter and stylet, without the need for general anesthesia or extended post-insertion monitoring.
“This innovative therapy brings new hope to bladder cancer patients after decades of limited progress,” said Jennifer Taubert, Executive Vice President, Worldwide Chairman of Innovative Medicine at Johnson & Johnson. “INLEXZO represents a breakthrough with the potential to change the standard of care.”
The FDA approval was based on results from the Phase 2b SunRISe-1 clinical trial, which demonstrated that 82% of patients treated with INLEXZO achieved a complete response, with 51% maintaining this response for at least one year. Common side effects included urinary frequency, urinary tract infections, and bladder irritation, among others.
Dr. Sia Daneshmand, principal investigator of the SunRISe-1 trial, highlighted the impact of the new treatment: “INLEXZO offers well-tolerated, clinically meaningful results that could change the treatment landscape for patients who have exhausted traditional therapies.”
Johnson & Johnson also emphasized their commitment to patient support through the J&J withMe program, which provides cost assistance, care navigation, and educational resources at no charge.
INLEXZO received FDA Breakthrough Therapy Designation, Real-Time Oncology Review, and Priority Review, underscoring the urgent need for new therapies in bladder cancer.
Bladder cancer affects millions globally, and neoadjuvant treatment options like INLEXZO provide a promising alternative to radical cystectomy, helping patients preserve their bladder and quality of life.