Johnson & Johnson (J&J) has secured the US Food and Drug Administration (FDA) Priority Review for TAR-200, its investigational intravesical gemcitabine-releasing system.
TAR-200 is indicated for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), regardless of papillary tumours.
J&J’s new drug application (NDA) is backed by data from the Phase 2b SunRISe-1 study, which showed an 82.4% complete response (CR) rate.
In the study, 52.9% of patients remained cancer-free for at least one-year post-CR.
Most adverse reactions include pollakiuria, dysuria, urinary tract infection, micturition urgency, haematuria, cystitis noninfective, and urinary tract pain.
Johnson & Johnson Innovative Medicine oncology global therapeutic area head Yusri Elsayed said: “TAR-200 represents an innovation in drug delivery that has not been seen in decades.
“The FDA Priority Review for TAR-200 underscores our mission to fundamentally change the way urologists treat certain types of bladder cancer.”
TAR-200 is the first intravesical drug-releasing system (iDRS) designed for sustained local delivery of cancer treatment into the bladder.
Inserted by a healthcare professional using a co-packaged urinary placement catheter in an outpatient setting, it remains in the bladder for three weeks per treatment cycle.
The procedure, which takes less than five minutes, requires no general anaesthesia or further monitoring immediately post-insertion.
In December 2023, the FDA granted Breakthrough Therapy Designation (BTD) to TAR-200 for treating BCG-unresponsive HR-NMIBC with CIS who are ineligible for radical cystectomy.
In January 2025, J&J initiated a new drug application with the FDA under the Real-Time Oncology Review (RTOR) programme.
TAR-200 is under evaluation in Phase 2 and 3 studies for non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) across several SunRISe trials.
