Long-term QUILT-3.032 findings show durable responses with Anktiva plus BCG in BCG-unresponsive NMIBC, with an estimated 84.2% cystectomy-free survival at 3 years.
News|Articles|January 28, 2025
Key FDA decisions urologists can expect in the first half of 2025
Author(s)Hannah Clarke
Check out the key regulatory decisions set to happen early this year.
Advertisement
Advertisement
There are a number of pending FDA approvals that urologists should keep an eye on as we move through the first half of the year. These include new agents in prostate and bladder cancer, as well as a novel therapeutic for uncomplicated urinary tract infections (uUTIs).
Related to this article
Vignesh Packiam, MD, discusses strategies to manage intravesical therapy toxicity in NMIBC, improve treatment tolerability, and preserve bladder function.
Sandip M. Prasad, MD, MPhil, discusses the safety profile of mitomycin intravesical solution, including common adverse events and patient counseling during chemoablation for NMIBC.
Sandip M. Prasad, MD, MPhil, discusses 3-year ENVISION trial data showing durable responses with mitomycin intravesical solution for recurrent LG-IR-NMIBC.
Armine K. Smith, MD, discusses sexual health counseling, sex-specific considerations, and organ-preserving approaches for patients undergoing radical cystectomy.
This approval expands the label for nogapendekin alfa inbakicept to include patients with high-grade papillary-only tumors.
Timothy N. Clinton, MD, recaps bladder cancer data from the 2026 AUA Northeastern Section meeting, including BOND-003 cretostimogene results and safety data on mitomycin intravesical solution.
Jack R. Andrews, MD, discusses BED-PSMA-411 findings comparing PSMA-PET detection rates and urinary excretion in prostate cancer biochemical recurrence.
Advertisement
Advertisement