gemcitabine intravesical system (Inlexzo, TAR-200): FDA status
Approved Approved Sep 9, 2025. Indication: BCG unresponsive high risk NMIBC with carcinoma in situ with or without papillary tumors. Company: Johnson and Johnson.
Regulatory history
- Sep 9, 2025: Approved. FDA approved Inlexzo for adults with BCG unresponsive NMIBC with CIS with or without papillary tumors based on SunRISe-1 cohort 2. fda.gov
- Aug 1, 2025: Priority review. TAR 200 received FDA priority review after 82 percent complete response rate in BCG unresponsive bladder cancer Oncodaily
- Jul 17, 2025: Priority review. FDA granted Priority Review to TAR-200 NDA for high risk NMIBC. Johnson & Johnson
- Jan 15, 2025: Application filed. Johnson and Johnson announced initiation of new drug application submission to FDA for TAR-200 in BCG unresponsive high risk NMIBC with CIS. urologytimes.com
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