May 9th 2024
Patients with Bacillus Calmette–Guérin-unresponsive high-risk non–muscle-invasive bladder cancer treated with TAR-200 exhibited a high complete response rate to the treatment.
TAR-200 Receives Breakthrough Therapy Designation From FDA for BCG-Unresponsive High-Risk NMIBC
January 14th 2024A breakthrough therapy designation has been granted by the FDA to TAR-200 for the treatment of Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle invasive bladder cancer who are not eligible for or opted not to receive radical cystectomy.
FDA Launches Priority Review of Enfortumab Vedotin Plus Pembrolizumab in Advanced Urothelial Cancer
December 4th 2023The FDA has granted enfortumab vedotin plus pembrolizumab priority review status for patients with locally advanced or metastatic urothelial cancer following data from the phase 3 EV-302/KEYNOTE-A39 trial.