Sasanlimab in Combination with BCG Improves EFS in Patients with BCG-Naïve, High-Risk NMIBC January 15, 2025
Cretostimogene Grenadenorepvec Monotherapy Data Demonstrates Sustained, Durable Complete Responses in High-Risk BCG-Unresponsive NMIBC December 10, 2024
Positive Results Announced from Ph 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC December 10, 2024
Imfinzi granted Priority Review in the US for patients with muscle-invasive bladder cancer December 10, 2024
FDA accepts NDA for UGN-102 (mitomycin) for intravesical solution for the treatment of LG-IR-NMIBC; PDUFA goal date: Jun 2025 October 22, 2024
Multiple Clinical Complete Responses Demonstrated Following Single Low Dose Administration of Bel-sar in Patients with NMIBC in Ongoing Ph 1 Trial October 22, 2024
Ph 3 SunRISe-2 trial in MIBC patients discontinued for not showing superiority versus chemoradiation October 15, 2024
First Patient Dosed in Ph 3 Clinical Trial of UGN-103 in patients with Low-Grade Intermediate-Risk NMIBC October 8, 2024
CHMP adopts positive opinion for BALVERSA (erdafitinib) in unresectable/metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations July 9, 2024
Imfinzi demonstrated statistically significant and clinically meaningful improvement in EFS and OS for MIBC in NIAGARA Ph 3 trial July 1, 2024
First-Patient-In Announced for Ph 1 Trial of IDE397 and Trodelvy® Combination in MTAP-Deletion Bladder Cancer July 1, 2024
Unprecedented 82.3% DOR at 12 Months in the ENVISION Trial Investigating UGN-102 as a Non-Surgical Treatment for LG-IR-NMIBC announced June 18, 2024
FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer May 15, 2024
Cretostimogene Monotherapy Demonstrated 75.2% Complete Response Rate in High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer May 7, 2024
TAR-200 monotherapy shows greater than 80% complete response rate in patients with high-risk NMIBC May 7, 2024
Results from ATLAS Showing Robust UGN-102 Durability of Response in New and Recurrent Low-Grade Intermediate-Risk NMIBC Announced May 7, 2024
Three-Year Follow-up Data in BCG-Unresponsive NMIBC Show Durable Response to Treatment with ADSTILADRIN (nadofaragene firadenovec-vncg) in 2 Patient Cohorts April 16, 2024
Positive Surveillance Analysis from the Randomized Ph 3 IMvigor011 Trial in MIBC announced April 8, 2024
China’s NMPA Accepts Supplemental BLA for enfortumab vedotin with KEYTRUDA for 1L Bladder Cancer April 2, 2024
Rolling NDA submitted to the FDA for UGN-102; 12-month duration of response data from ENVISION expected to support completion of NDA submission March 19, 2024
U.S. FDA Approves Opdivo + Cisplatin + Gemcitabine for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma March 12, 2024
