强生(JNJ.US)获FDA批准突破性疗法 超80%患者肿瘤完全消失

Core Insights - Johnson & Johnson (JNJ.US) announced that the FDA has approved its innovative drug Inlexzo for treating adult non-muscle invasive bladder cancer (NMIBC) patients who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy, with or without papillary tumors [2] - The approval is based on data from the SunRISe-1 Phase 2b clinical trial, which showed that 82% of BCG-unresponsive NMIBC patients achieved complete response (CR), meaning no signs of cancer were observed post-treatment [2] - The high response rate demonstrated significant durability, with 51% of patients maintaining complete response for at least one year [2] - Inlexzo is designed for patients wishing to preserve their bladder and is the first approved system capable of continuously releasing chemotherapy drugs within the bladder [2] Summary by Sections - FDA Approval: Inlexzo has received FDA approval for NMIBC patients unresponsive to BCG therapy [2] - Clinical Trial Results: The SunRISe-1 trial indicated an 82% complete response rate among treated patients, with a confidence interval of 95% (72-90) [2] - Durability of Response: 51% of patients maintained complete response for a minimum of one year, indicating the treatment's effectiveness over time [2] - Drug Delivery System: Inlexzo (TAR-200) is a bladder drug delivery system designed for sustained local release of gemcitabine, maintaining drug exposure for several weeks [2]