Bladder Cancer

CG Oncology plans to initiate a BLA submission with the FDA in Q4 of 2025.

The LEGEND trial is evaluating detalimogene voraplasmid in patients with high-risk non–muscle invasive bladder cancer.

The trial is assessing RFS rates with cretostimogene grenadenorepvec vs surveillance following TURBT.

Predicine has submitted the first module of a PMA application for their urine cfDNA NGS assay PredicineCARE.

Take a look through the novel agents that are set to further redefine the treatment landscape for high-risk BCG-unresponsive NMIBC.

Robert B. Den, MD, outlines the exploratory applications of the Alpha DaRT technology across the prostate and bladder cancer landscapes.

The company is engaged in discussions with the FDA surrounding the initiation of a pivotal phase 3 trial of Alpha1H.

Patients who were Signatera positive and received treatment with atezolizumab had a statistically significant and clinically meaningful improvement in DFS and OS.

The ARCHER trial is seeking to determine whether ultra-hypofractionated radiotherapy is non-inferior to hypofractionated radiotherapy in terms of bladder-intact event-free survival.

Sandip M. Prasad, MD, MPhil, shares his thoughts on the impact of the FDA approval of mitomycin for intravesical solution for patients with LG-IR-NMIBC.

An interim analysis of the data showed that the trial met its primary end point of EFS, as well as the key secondary end points of OS and pCR rate.

This marks the first and only approval of a perioperative immunotherapy in this disease setting in Canada.

Suzanne B. Merrill, MD, FACS explains the challenges with BCG monotherapy and the emergence of novel regimens combining BCG with ICIs in high-risk NMIBC.

In the phase 3 RC48-C016 study, disitamab vedotin plus toripalimab significantly improved PFS and OS vs chemotherapy.

In this interview, Tom Jayram, MD, offers insights into how BCG plus immune checkpoint inhibitors may redefine the treatment landscape in BCG-naïve NMIBC.

A phase 3 registrational trial of NDV-01 is expected in the first half of 2026.

Take a look through key stories from last month, including regulatory news, trial updates, and other practice-changing advancements.

FX-909 is an investigational small molecule PPARG inhibitor for patients with locally advanced or metastatic urothelial carcinoma.

Treatment with mitomycin for intravesical solution led to a 24-month DOR of 72.2% among patients who achieved an initial complete response.

A recap of the FDA submissions and regulatory decisions in urology from July 2025.

From a practical standpoint, integrating ctDNA into clinical practice poses challenges.

Data show that TAR-200 monotherapy led to high complete response rates and encouraging DFS in patients with BCG-unresponsive high-risk NMIBC.

Data from the phase 3b study were recently published in Reviews in Urology, showing that administration of mitomycin intravesical solution in the home setting was feasible, safe, and effective.

Ultimately, the take-home message for practicing urologists is to apply TMT judiciously, taking into account the patient's clinical profile, personal values, and financial situation.

Betty Wang, MD, said she envisions ctDNA integrating into existing surveillance protocols for patients with high-risk NMIBC.

Mitomycin intravesical solution was granted FDA approval in June 2025 for recurrent LG-IR-NMIBC.

Take a look back through some of the top stories from the first half of the year.

The new drug application for TAR-200 is supported by data from cohort 2 of the phase 2b SunRISe-1 trial.

The Continuity Grant will support projects in bladder cancer and/or upper tract urothelial carcinoma that were previously scientifically reviewed, approved, and funded.

Alpha1H was granted a fast track designation in November 2023.