Bladder Cancer

Jason M. Hafron, MD, CMO, discusses recent approvals in the non–muscle-invasive bladder cancer space and data from several clinical trials evaluating agents for bladder cancer.

Treatment of unresponsive non–muscle-invasive bladder cancer with nadofaragene firadenovec showed a 66% chance of survival and cystectomy-free status at 60 months.

Given different scientific and clinical meeting schedules, considering advances in genitourinary oncology in novel therapies is relevant.

Funda Meric-Bernstam, MD, discusses updated findings from the phase 1 TROPION-PanTumor01 study of datopotamab deruxtecan-dlnk in heavily pretreated locally advanced or metastatic urothelial cancer.

In separate, live virtual events, David H. Aggen, MD, PhD; and Matthew R. Zibelman, MD, discussed the case of a patient with urothelial carcinoma and potential treatment options.

Shilpa Gupta, MD, discusses the key takeaways from the long-term outcomes of the JAVELIN Bladder 100 trial for community oncologists.

Avelumab plus best supportive care improved survival vs best supportive care alone in advanced urothelial carcinoma, regardless of diabetes status.

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.