- In April 2025, UroGen Pharma announced encouraging Phase 1 dose-escalation results for UGN‑301 (zalifrelimab) in patients with non-muscle invasive bladder cancer (NMIBC), showing 46% of Ta/T1 patients and 33% of CIS patients remained recurrence-free or achieved a complete response at 12 weeks; 60% of Ta/T1 patients on the 300 mg dose were still disease-free at 15 months
- In February 2025, Astellas Pharma reported that China’s NMPA approved enfortumab vedotin (PADCEV) in combination with pembrolizumab as a first-line treatment for advanced or metastatic urothelial carcinoma, representing the first non–platinum-based regimen in this setting and expanding treatment alternatives for patients in China
- In December 2022, Ferring Pharmaceuticals received U.S. FDA approval for Adstiladrin (nadofaragene firadenovec-vncg), the first intravesical gene therapy for high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Over half (51%) of CIS±Ta/T1 patients achieved a complete response at 3 months, with 46% remaining disease-free at 12 months
- In March 2025, Relmada Therapeutics announced licensing of NDV‑01, a Phase 2 bladder cancer candidate from Trigone Pharma. This new compound will be added to Relmada’s portfolio to support ongoing clinical evaluations in bladder cancer indications, reinforcing development pipelines for advanced therapies
