Opinion|Videos|February 5, 2025
Recent FDA Approvals in NMIBC
Author(s)Mark D. Tyson, MD, MPH, Gary D. Steinberg, MD
Panelists discuss how FDA approvals have expanded options for BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC), with pembrolizumab, nogapendekin alfa inbakicept-pmln, and nadofaragene firadenovec-vncg offering new immunotherapy and gene therapy approaches.
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Episodes in this series
Video content above is prompted by the following:
- How has the treatment landscape of NMIBC changed in recent years to provide better options for patients?
- Provide an overview of recent FDA approvals, including for the treatment of high-risk, BCG-unresponsive NMIBC (pembrolizumab [PD-1 inhibitor], nogapendekin alfa inbakicept-pmln [immunotherapy], and nadofaragene firadenovec-vncg [gene therapy]).
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Related to this article
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.
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.
Sandip Prasad, MD, MPhil, discusses ENVISION trial findings on mitomycin for intravesical solution and patient selection in clinical practice.
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