MAA submitted to the EMA for Approval of Erdafitinib in Patients with Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations September 14, 2023
Supplemental NDA submitted to FDA for Full Approval of BALVERSA® (erdafitinib) for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma September 6, 2023
Tecentriq subcutaneous (SC) is approved in Great Britain for all indications of IV Tecentriq, offering a faster, more convenient option to receive treatment September 6, 2023
Supplemental NDA submitted to FDA for Full Approval of BALVERSA for the Treatment of Patients with Locally Advanced/Met Urothelial Carcinoma with Selected FGFR Gene Alterations September 6, 2023
CG Oncology Announces $105 Million Oversubscribed Crossover Financing to Support Continued Advancement of Clinical-Stage Bladder Cancer Pipeline August 9, 2023
UGN-102 Met Primary Endpoints in Both Phase 3 ATLAS and ENVISION Clinical Trials in NMIBC patients August 2, 2023
Opdivo + Chemo Shows OS & PFS Benefit for Cisplatin-Eligible Patients with Unresectable or Metastatic Urothelial Carcinoma in the Phase 3 CheckMate -901 Trial July 19, 2023
First Results from Ph 2 SunRISe-1 Study of TAR-200 and Cetrelimab in Patients with BCG-Unresponsive NMIBC announced May 10, 2023
Positive Preliminary Data announced from ADVANCED-1 Ph 1a Dose Escalation Trial of TARA-002 in NMIBC Supporting Advancement into Ph 2 Clinical Development May 10, 2023
FDA Approves KEYTRUDA + Padcev combination for 1L Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer April 12, 2023
Merck Strengthens Oncology Franchise by Securing Exclusive Worldwide Rights to Anti PD-L1 Antibody BAVENCIO® (avelumab) March 31, 2023
First Patient Dosed in ASPEN-07 Ph 1 Study of Evorpacept for the Treatment of Patients with Urothelial Cancer February 22, 2023
Trodelvy® Demonstrates Positive Efficacy Treating Both Platinum-Ineligible And Rapidly Progressing, Post-Platinum Metastatic Urothelial Cancer February 22, 2023
New Analyses Reinforce Survival Benefit of BAVENCIO First-Line Maintenance Treatment in Patients With Advanced Urothelial Carcinoma February 22, 2023
First Patient Dosed in NMIBC Substudy of the LUMINOS-103 Basket Trial Evaluating Lerapolturev Monotherapy February 8, 2023
Results of the First Post-Commercial Utilization Review of JELMYTO® Provide New Evidence that Reinforces its Efficacy and Safety in Patients with Low-Grade Upper Tract Urothelial Cancer January 17, 2023
Upcoming 2023 Readouts from Phase 2 and Pivotal Phase 3 Clinical Trials of Trilaciclib announced January 17, 2023
Initial update on Ph 2 PRESERVE 3 trial of 1L platinum-based chemo and maintenance avelumab +/- trilaciclib in patients with 1L locally advanced or metastatic urothelial carcinoma announced January 11, 2023
FDA Accepts Supplemental BLA for PADCEV® (enfortumab vedotin-ejfv) + KEYTRUDA for 1L Locally Advanced or Metastatic Urothelial Cancer patients January 4, 2023
FDA approved Adstiladrin for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer January 4, 2023
New Data from the OPTIMA II Study Shows mDOR of 24.4 Months for UGN-102 in patients with Low-Grade, Intermediate-Risk Non-Muscle Invasive Bladder Cancer December 12, 2022
Immutep Enters into 2nd Clinical Trial Collaboration Agreement with Merck & Pfizer for New trial of Eftilagimod Alpha and Avelumab to Treat Urothelial Cancer December 5, 2022
New Data from the OLYMPUS Trial Shows mDOR of 28.9 Months for JELMYTO for Adults with Low-Grade Upper Tract Urothelial Cancer December 5, 2022
