Overview

• The FDA cleared Inlexzo (formerly TAR‑200) for adults with high‑risk non–muscle‑invasive bladder cancer with carcinoma in situ, with or without papillary tumors, after BCG failure.
• Approval rests on Phase 2b SunRISe‑1 data showing an 82.4% confirmed complete response at three months, with about half of responders maintaining a complete response for at least one year.
• Inlexzo is inserted into the bladder to deliver low‑dose gemcitabine locally and remains in place for three weeks per treatment cycle for up to 14 cycles.
• Placement is performed in an outpatient setting via a urinary catheter in under five minutes with no general anesthesia.
• Most adverse reactions were mild to moderate, commonly including urinary frequency, urinary tract infection and dysuria; the approval followed priority review in recognition of unmet need.