Raritan:Johnson & Johnsonhas received approval from the U.S. Food and Drug Administration (FDA) for INLEXZO (gemcitabine intravesical system), a new, potentially practice-changing approach for treating patients with certain types ofbladder cancer, addressing the need for additional options following unsuccessful BCG therapy and for patients refusing or ineligible for bladder removal surgery (radical cystectomy). INLEXZO, previously referred to as TAR-200, is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO is designed for patients seeking bladder preservation and is an intravesical drug releasing system (iDRS) to provide extended local delivery of a cancer medication into the bladder. INLEXZO remains in the bladder for three weeks per treatment cycle for up to 14 cycles. A healthcare professional places INLEXZO into the bladder using a co-packaged urinary catheter and stylet to insert it into the bladder.INLEXZO is placed in an outpatient setting in a few minutes, without the need for general anesthesia or further monitoring immediately post-insertion within the healthcare provider’s office. “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, 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.” The approval is supported by data from the SunRISe-1 ( NCT04640623) single arm, open-label Phase 2b clinical study. Results show 82 percent of patients with BCG-unresponsive NMIBC treated with INLEXZO achieved a complete response (CR), meaning no signs of cancer were found after treatment (95 percent confidence interval [CI], 72, 90). This high response rate demonstrated strong durability, and 51 percent of these patients maintained a complete response for at least one year. “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., TAR-200 SunRISe-1 principal investigator, and Professor of Urology, Director of Urologic Oncology at the Norris Comprehensive Cancer Center, Keck School of Medicine of 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.” “We are proud of the science that has brought us to this historic moment,” said John Reed, M.D., Ph.D., Executive Vice President, R&D, Innovative Medicine, Johnson & Johnson. “INLEXZO is a novel therapy with powerful efficacy and 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.” “At BCAN, our mission has always been to advocate for better todays and more tomorrows for everyone impacted by bladder cancer. This approval represents the kind of progress that brings new options to a community that urgently needs them,” said Meri-Margaret Deoudes, CEO, Bladder Cancer Advocacy Network (BCAN).** “Patients with bladder cancer need guidance and collaboration with providers to navigate bladder-sparing treatment options, including newly approved treatments like INLEXZO, so they can move forward feeling well-informed and confident.” Leading to the approval, the FDA granted INLEXZO Breakthrough Therapy Designation (BTD), Real-Time Oncology Review (RTOR), and Priority Review. Non-muscle invasive bladder cancer (NMIBC) is a type of non-invasive bladder cancer that can be classified as low, intermediate, or high risk depending on the presence of characteristics including tumor size, presence of multiple tumors, and carcinoma in situ (CIS). NMIBC with CIS makes up approximately 10 percent of patients with NMIBC. The current standard of care for NMIBC is Bacillus Calmette-Guérin (BCG), which is a weakened form of the bacteria found in tuberculosis treatment. Though effective, some patients become unresponsive to it and may experience challenges. Radical cystectomy is currently recommended for NMIBC patients who fail BCG therapy; it is a life-altering surgery with a high degree of morbidity and adverse impact on life, and has a post-surgery mortality rate of three to eight percent. Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.