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
The combination of nogapendekin alfa inbakicept plus BCG demonstrated a statistically significant improvement in efficacy vs BCG alone.
Patient goals, disease features, and response to prior therapy guide treatment choices across high-risk NMIBC, according to Suzanne B. Merrill, MD, FACS.
Suzanne B. Merrill, MD, discusses emerging perioperative approaches in MIBC and the potential for more personalized treatment selection based on disease characteristics.
BCG monotherapy and a high-quality TURBT remain the foundation for BCG-naive high-risk NMIBC, according to Vignesh T. Packiam, MD.
Patient priorities and practice logistics should guide therapy selection in BCG-unresponsive NMIBC, according to Katie S. Murray, DO, MS, FACS.
Systemic therapy now anchors MIBC care and expands bladder preservation options, according to Joshua J. Meeks, MD, PhD.
BCG optimization should precede checkpoint inhibitor intensification in BCG-naive high-risk NMIBC, according to Tom Jayram, MD.
The phase 1 study is intended to characterize the safety, tolerability, and feasibility of intravesical administration of UGN-501.
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