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Pre-Approval Expanded Access Study for TAR-200 Treating Physician Use
Sponsor: Janssen Research & Development, LLC
Summary
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).
Official title: Pre-Approval Access US Intermediate Size Expanded Access Protocol for TAR-200 Treating Physician Use
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
EXPANDED_ACCESS
Enrollment
Not specified
Start Date
Not specified
Completion Date
Not specified
Last Updated
2026-09-25
Healthy Volunteers
Not specified
Conditions
Interventions
TAR-200
Participants will undergo insertion of TAR-200 transurethrally into the bladder via catherization using the co-packed urinary placement catheter only in accordance with the Instructions for Use (IFU).