Bladder Cancer

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

A comprehensive guide to the key regulatory decisions and conferences slated for the last few months of the year.

Take a look through the key trials investigating BCG/ICI combinations in BCG-naïve NMIBC.

Tom Jayram, MD, discusses rationale for selective FGFR3 inhibition in bladder cancer as well as what’s needed to bring this treatment modality into routine clinical practice.

The NDA is supported by data from a phase 3 trial, which demonstrated a 75% complete response rate at 3 months.

Siamak Daneshmand, MD, shares his thoughts on the impact of the gemcitabine releasing system for clinical practice.

Data from the SunRISe-1 trial showed a complete response rate of 82%, with 51% of patients remaining in complete response for at least 1 year.

At the time of data report, the median progression-free survival and duration of response had not been reached in either cohort.

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.

Sandip M. Prasad, MD, MPhil, outlines 3 key takeaways from the ENVISION trial, which evaluated mitomycin for intravesical solution in patients with LG-IR-NMIBC.

Sandip M. Prasad, MD, MPhil, discusses the safety profile for mitomycin for intravesical solution based on data from the ENVISION trial.

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.

Sandip M. Prasad, MD, MPhil, details key findings from the phase 3 ENVISION trial, which supported the approval of mitomycin intravesical solution in LG-IR-NMIBC.

Suzanne B. Merrill, MD, FACS, unpacks key findings from the CREST trial and outlines data of interest from the POTOMAC and PATAPSCO trials, which are set to read out later this year.

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.

Urologists from the University of North Carolina share insights into key advancements across the field of urologic oncology.

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.