The purpose of this pre-approval access program is to provide access to TAR-200 prior to its marketing authorization for the treatment of participant(s) with high-risk non-muscle invasive bladder cancer (HR-NMIBC).
Protocol Amendment History
14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2025-03-10; most recent amendment 2026-07-02.
Status change: Available → Approved For Marketing2025-09-15