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
One year following the approval of the gemcitabine intravesical system, Joseph Jacob, MD, reflects on the expanding treatment landscape in BCG-unresponsive NMIBC.
The PDUFA target action date is in the fourth quarter of 2026.
Sandip Prasad, MD, discusses patient selection for chemoablation in recurrent LG-IR-NMIBC and considerations when counseling patients about a nonsurgical approach.
Enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) showed the strongest EFS, OS, and pCR associations among neoadjuvant MIBC strategies in a network meta-analysis, although perioperative design limits attribution.
Sandip Prasad, MD, MPhil, discusses the evolving role of chemoablation in recurrent low-grade, intermediate-risk NMIBC, including patient selection and treatment considerations.
Eugene Cone, MD, discusses recombinant BCG for NMIBC, including ongoing clinical evaluation and its potential to address ongoing BCG supply challenges.
A decision is expected by the fourth quarter of 2026.
Eugene Cone, MD, discusses SWOG S1602 findings comparing Tokyo-172 and TICE BCG and the potential role of alternative BCG strains in NMIBC
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