Johnson & Johnson has submitted an original new drug application (NDA) to the US Food and Drug Administration (FDA) for TAR-200, an intravesical drug releasing system.
This treatment targets Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with or without carcinoma in situ (CIS), and with or without papillary tumours.
The submission is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) programme, which enables the agency to assess the data before completing the full application.
TAR-200 is an investigational system designed for sustained local delivery of gemcitabine into the bladder.
It is placed into the bladder by a healthcare professional using a co-packaged urinary placement catheter. This process requires less than five minutes, does not necessitate anaesthesia, and is conducted in an outpatient setting.
In December 2023, the FDA granted breakthrough therapy designation (BTD) to TAR-200 for treating adult patients with BCG-unresponsive HR-NMIBC with CIS who are ineligible for or have chosen not to undergo radical cystectomy.
TAR-200 is part of the Taris platform, which Johnson & Johnson acquired in late 2019 through the acquisition of Taris Biomedical.
Johnson & Johnson innovative medicine oncology global therapeutic head Yusri Elsayed said: “Upon approval, TAR-200 promises to be a meaningful additional treatment option for certain patients with NMIBC, addressing a critical need for people who have had relatively limited therapeutic alternatives.
“Many patients face life-altering surgical options such as radical cystectomy, which is complete bladder removal.
“By combining our expertise in innovative medicine and medical devices, Johnson & Johnson is uniquely positioned to transform how we treat certain types of bladder cancer through the first and only intravesical drug releasing system for this disease.
“We look forward to working with the FDA in review of this application.”
The submission of TAR-200 is backed by data from the Phase 2b SunRISe-1 registration study.
Data collected through Q2 2024 showed an 83.5% complete response (CR) rate, with highly durable CRs observed without the need for reinduction. It also showed 82% of responders maintained their response at a median follow-up of nine months.
Safety data from May 2024 revealed a low rate of Grade 3 or higher treatment-related adverse events (TRAEs) at 9%, with 6% of patients discontinuing treatment due to TRAEs and no treatment-related deaths.
