Bladder Cancer

The agency made the designation on the basis of recently reported data from the phase 3 CheckMate 274 trial that found a statistically significant improvement in disease-free survival in patients treated with the PD-1 inhibitor.

"After a long period of stagnation and inertia, the bladder cancer space is alive and full of innovation and activation," writes Michael S. Cookson, MD, MMHC.

Myriad therapies in the pipeline will change treatment landscape.

Padeliporfin ImPACT previously received FDA Fast Track and Orphan Drug designations for the treatment of patients with upper tract urothelial cancer.

The applications are supported by data from the EV-301 and EV-201 trials.

Galsky highlights final OS data from the IMvigor130 trial, along with an exploratory analysis examining outcomes by type of chemotherapy used.

The FDA has approves sacituzumab govitecan (Trodelvy) for patients with prevviously treated locally advanced or metastatic urothelial cancer.

Michael Devitt, MD, discusses the choice between erdafitinib and enfortumab vedotin in previously treated urothelial carcinoma.

The panel recommended adding data from the phase 3 KEYNOTE-361 trial to the label for pembrolizumab for its indication for patients with advanced or metastatic urothelial carcinoma.

The application is supported by findings from the phase 3 EV-301 trial.

“This study represents the most comprehensive analysis to date of tumor mutation burden as a biomarker for response to immune checkpoint blockade,” according to lead study author Daniel J. McGrail, PhD.

Watch the on-demand video of Urology Times' March 2021 Around the Practice.

Investigational agents on the horizon include Vicineum, nadofaragene firadenovec, and N-803 (Anktiva).

The treatment paradigm in upper tract urothelial carcinoma (UTUC) is rapidly evolving, particularly with the FDA approving mitomycin gel (Jelmyto) as the first therapy to treat low-grade UTUC.

Case study of a patient with muscle-invasive bladder cancer.

The safety and efficacy of the locally administered fusion protein were assessed in the phase 3 VISTA trial.

The investigational padeliporfin ImPACT platform involves the intravenous delivery of the photosensitive drug padeliporfin, which is then activated by a non-thermal light delivery system.

The withdrawal comes after the confirmatory phase 3 IMvigor211 study missed its primary end point.

Treatment following progression on chemotherapy and an immune checkpoint inhibitor remains an unmet medical need.

Shaakir Hasan, DO, discusses socioeconomic characteristics associated with the diagnosis and management of bladder cancer.

The subgroup analysis assessed data from the pivotal phase 3 JAVELIN Bladder 100 trial showed.

“[Urologists are] very comfortable giving agents in the bladder, so [CG0070] really fits in line with what we give,” says investigator Edward Uchio, MD.

Based on these findings, an application has been filed with the FDA to expand enfortumab vedotin’s approval to include cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor.

Boorjian anticipates research with nadofaragene firadenovec in settings beyond BCG-unresponsive non-muscle invasive bladder cancer.

"Our study demonstrates the feasibility of HIVEC MMC and suggests it is a reasonable substitute for BCG during global shortages," says urologist Scott P. Campbell, MD.

The withdrawal comes after the confirmatory phase 3 DANUBE trial missed its primary end points.

Adjuvant treatment with the anti–PD-1 immunotherapy significantly extended the time period after primary treatment in which patients had no signs or symptoms of cancer.

Determining grade of disease is important, as nephron-sparing approaches may be feasible.