Bladder Cancer

Third-line enfortumab vedotin improved outcomes in metastatic urothelial carcinoma, per real-world data from the EV-301 trial.

Enfortumab vedotin plus pembrolizumab doubled progression-free survival vs chemotherapy in urothelial cancer.

Datopotamab deruxtecan showed promising activity in advanced urothelial cancer in a phase 1 study.

UGN-102 led to durable responses in low-grade, intermediate-risk bladder cancer, per phase 3 study findings at the 2025 Genitourinary Cancers Symposium.

An FDA application for TAR-200 to treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer is under real-time oncology review, expediting access to this potential treatment.

TYRA-300 has gained an investigational new drug application from the FDA and will be further studied in the phase 2 SURF302 trial for patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer.

Petros Grivas, MD, PhD, discusses the key trials of bladder cancer using immunotherapy he highlighted during a Case-Based Roundtable event.

If approved, durvalumab will be the first and only perioperative immunotherapy regimen available for the treatment of patients with muscle-invasive bladder cancer in this curative-intent setting.

Antoni Vilaseca Cabo, MD, discusses the rationale behind the phase 1 study evaluating the safety and efficacy of TAR-210 in patients with FGFR-altered high- and intermediate-risk non–muscle invasive bladder cancer.

Petros Grivas, MD, PhD, elaborates on some key unanswered questions on approaches to bladder cancer treatment he discussed with participants at a Case-Based Roundtable event.

In an interview, Antoni Vilaseca Cabo, MD, discussed the clinical activity of TAR-210 in patients with non-muscle invasive bladder cancer.

Rana R. McKay, MD, discusses the significance of clinical trial data for immunotherapy in muscle-invasive bladder cancer (MIBC) treatment she presented at a Case-Based Roundtable event.

The FDA is currently evaluating the application of intravesical mitomycin for low-grade intermediate-risk non–muscle-invasive bladder cancer.

TYRA-300 showed promising safety and preliminary antitumor activity in FGFR3-altered metastatic urothelial cancer, with a 54.5% partial response rate and 100% disease control in the SURF301 trial.

Gilead, manufacturer of the TROP2-directed antibody-drug conjugate sacituzumab govitecan, made the decision to withdraw the agent in consultation with the FDA.

A Prescription Drug User Fee Act target action date of June 13, 2025, has been set for the new drug application of intravesical mitomycin.

The SunRISe-2 trial evaluating TAR-200 combined with cetrelimab vs chemoradiation in muscle-invasive bladder cancer has been discontinued.

Results from cohort 2 of the TROPHY-U-01 study showed that sacitizumab govitecan led to rapid responses in patients with locally advanced or metastatic urothelial carcinoma.

Given as neoadjuvant treatment, TAR-200 plus cetrelimab generated responses in patients with muscle-invasive bladder cancer.

In the NIAGARA trial, significant event-free survival and overall survival gains were observed with neoadjuvant durvalumab plus chemotherapy, followed by adjuvant durvalumab in cisplatin-eligible bladder cancer.

Longer follow-up from the phase 3 AMBASSADOR trial showed adjuvant pembrolizumab to demonstrate a statistically significant and clinically meaningful improvement in disease-free survival in patients with high-risk muscle-invasive urothelial carcinoma.

A new drug application has been submitted to the FDA for UGN-102, an intravesical solution for treating low-grade, intermediate-risk non–muscle-invasive bladder cancer.

Mark D. Tyson, II, MD, MPH, discussed treatment with cretostimogene grenadenorepvec in high-risk Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ and data from the BOND-003 trial.

Vikram Narayan, MD, discussed the durable clinical activity observed with nadofaragene firadenovec in the CS-003 trial for patients with non-muscle invasive bladder cancer.

Combining durvalumab with chemotherapy in the NIAGARA trial led to significant improvements in event-free survival and overall survival for patients with muscle-invasive bladder cancer.