New Drug Application initiated with U.S. FDA for TAR-200, the …
6 days ago · In December 2023, the FDA granted Breakthrough Therapy Designation (BTD) to TAR-200 for the treatment of adult patients with BCG-unresponsive HR-NMIBC with CIS who …
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 …
TAR-200 - SunRISe-1 Study - jnjmedicalconnect.com
5 days ago · SunRISe-1 (NCT04640623) is an ongoing, phase 2b, randomized, open-label, multicenter study evaluating the efficacy and safety of intravesical TAR-200 plus systemic …
Development of TAR-200: A novel targeted releasing system …
6 days ago · TAR-200 is a single-compartment, targeted releasing system designed to provide sustained intravesical gemcitabine [23]. TAR-200 elutes a sustained dose of drug to increase …
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 …
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 …
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.
FDA Approval Is Sought for TAR-200 in BCG-Unresponsive High …
5 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 …
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 …
FDA Considers TAR-200 in BCG-Unresponsive High-Risk NMIBC
5 days ago · The FDA has received a new drug application for TAR-200 for Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with …
- Some results have been removed