J&J(US:JNJ) Prnewswire·2025-09-09 20:18Core Viewpoint - Johnson & Johnson's INLEXZO™ has received FDA approval as a novel treatment for BCG-unresponsive non-muscle invasive bladder cancer, offering a new option for patients who have limited alternatives before considering bladder removal surgery [1][3][9]. Group 1: Product Overview - INLEXZO™ is the first and only intravesical drug releasing system designed for extended local delivery of gemcitabine into the bladder, remaining in place for three weeks per treatment cycle for up to 14 cycles [2][9]. - The treatment is administered in an outpatient setting without the need for general anesthesia, allowing for quick insertion using a co-packaged urinary catheter [2][9]. Group 2: Clinical Efficacy - In the SunRISe-1 clinical trial, 82% of patients with BCG-unresponsive NMIBC achieved a complete response, with 51% maintaining this response for at least one year [3][7]. - The trial demonstrated strong durability of the treatment, indicating a significant breakthrough in an area with little progress over the past 40 years [3][6]. Group 3: Safety Profile - The most common adverse reactions reported (15% or more) included urinary frequency, urinary tract infection, and dysuria, among others [4][19]. - Serious adverse reactions occurred in 24% of patients, with fatal reactions reported in 1.2% of cases [18][19]. Group 4: Market Context - Non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) represents about 10% of NMIBC patients, and the current standard of care is BCG therapy, which some patients become unresponsive to [8][11]. - Radical cystectomy is often recommended for patients who fail BCG therapy, but it carries significant risks and is not suitable for all patients, particularly older individuals [8][11]. Group 5: Regulatory Milestones - The FDA granted INLEXZO™ Breakthrough Therapy Designation, Real-Time Oncology Review, and Priority Review, highlighting its potential impact on patient care [6][9]. Group 6: Patient Support Initiatives - Johnson & Johnson has established a patient support program, J&J withMe, to assist patients in accessing INLEXZO™, providing cost support and educational resources at no cost [6].