TAR-200 - General Overview - jnjmedicalconnect.com
Dec 5, 2024 · TAR-200 (JNJ-17000139) is an investigational intravesical system that is designed to provide local release of gemcitabine in the bladder. TAR-200 contains gemcitabine and urea mini tablets within a dual-lumen silicone tube for gradual release of gemcitabine by an osmotic delivery mechanism throughout the prescribed indwelling period. 1-6
Johnson & Johnson’s Investigational TAR-200 Granted U.S. FDA ...
Dec 4, 2023 · TAR-200 is an investigational targeted releasing system enabling controlled release of gemcitabine into the bladder, sustaining local drug exposure for weeks at a time. The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with muscle-invasive bladder cancer in SunRISe-2 and SunRISe-4 and NMIBC in ...
TAR-200 monotherapy shows greater than 80% complete …
May 3, 2024 · TAR-200 is an investigational targeted releasing system designed to provide extended local release of gemcitabine into the bladder. It is installed in a physician’s office setting during a 3- to 5-minute procedure with no anesthesia.
TAR-200 - SunRISe-1 Study - jnjmedicalconnect.com
Dec 5, 2024 · SunRISe-1 (NCT04640623) is an ongoing, phase 2b, randomized, open-label, multicenter study evaluating the efficacy and safety of intravesical TAR-200 plus systemic cetrelimab, an investigational immunoglobulin G4 (IgG4) antibody that targets the programmed cell death protein-1 (PD-1) receptor, TAR-200 alone, or cetrelimab alone in patients with ...
Neoadjuvant TAR-200 plus cetrelimab nearly doubles the …
Sep 16, 2024 · TAR-200 is an investigational targeted releasing system designed to provide extended local release of gemcitabine into the bladder. It is installed in a physician’s office setting during a 2-3 minute procedure with no anesthesia.
New Drug Application initiated with FDA for TAR-200 for NMIBC
3 days ago · The FDA previously granted TAR-200 a breakthrough therapy designation in December 2023 for the treatment of patients with BCG-unresponsive high-risk NMIBC with CIS who are ineligible for or have elected to not undergo radical cystectomy. "Upon approval, TAR-200 promises to be a meaningful additional treatment option for certain patients with ...
FDA Approval Is Sought for TAR-200 in BCG-Unresponsive High …
2 days ago · Key Takeaways. TAR-200 demonstrated an 83.5% complete response rate in high-risk NMIBC with CIS, supported by the SunRISE-1 trial data. The trial's primary endpoint was overall complete response ...
Johnson & Johnson Initiates New Drug Application for TAR-200 in …
3 days ago · The New Drug Application for TAR-200 is supported by results from the Phase IIb SunRISe-1 study, which demonstrated an 83.5% complete response in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer. Johnson & Johnson announced the initiation of a New ...
Safety, Tolerability, and Preliminary Efficacy of TAR-200 in Patients ...
May 1, 2023 · TAR-200 is a novel, intravesical drug delivery system that provides sustained, local release of gemcitabine into the bladder over a 21-day dosing cycle.
TAR-200 - Poster Summary: Project Penelope
Dec 23, 2024 · TAR-200 (JNJ-17000139) is an investigational intravesical system that is designed to provide local release of gemcitabine in the bladder. TAR-200 contains gemcitabine and urea mini tablets within a dual-lumen silicone tube for gradual release of gemcitabine by an osmotic delivery mechanism throughout the prescribed indwelling period. 1 - 5
- Some results have been removed