TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer December 11, 2023
FDA Accepts for Priority Review Application for Opdivo + Cisplatin-Based Chemo for the 1L Treatment of Adult Patients with Unresectable/Metastatic urothelial carcinoma December 11, 2023
New Data Show Durable Response Following Treatment with ADSTILADRIN® (nadofaragene firadenovec-vncg) December 11, 2023
FDA Grants Priority Review to Supplemental BLA for KEYTRUDA Plus PADCEV for the 1L Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer December 4, 2023
Subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types December 4, 2023
Resubmission of BLA for N-803 + BCG for the treatment of BCG-unresponsive NMIBC accepted; new PDUFA date of April 23, 2024 October 31, 2023
First Patients Dosed in First-in-Human Ph 1 Study of FX-909 in Advanced Solid Tumors, Including Urothelial Cancer October 25, 2023
KEYTRUDA® Met Primary Endpoint of DFS in Certain Patients With Muscle-Invasive Urothelial Carcinoma (MIUC) After Surgery October 11, 2023
First Patient in Ph 1b/2 ADVANCED-2 Trial of TARA-002 in NMIBC Patients with High Grade Carcinoma in Situ September 26, 2023
PADCEV and KEYTRUDA Significantly Improve OS and PFS in Patients With Previously Untreated Advanced Bladder Cancer in Ph 3 EV-302 Trial September 26, 2023
Ph 3 KEYNOTE-A39/EV-302 Trial Met Dual Primary Endpoints of OS and PFS in Certain Patients With 1L Locally Advanced or Metastatic Urothelial Cancer September 26, 2023
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
