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Opinion|Videos|December 19, 2024
Treatment Strategies for Patients with NMIBC: Importance of Risk Stratification
Author(s)Mark D. Tyson II, M.D., M.P.H.
A panelist discusses how Non-muscle Invasive Bladder Cancer (NMIBC) treatment varies by risk stratification (low, intermediate, and high-risk), with BCG immunotherapy being standard for high-risk patients, while newer options like pembrolizumab and gene therapies are emerging for BCG-unresponsive cases, and treatment decisions between intravesical versus systemic therapy depend on risk level and previous treatment response.
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- Please share where the field of Non-muscle Invasive Bladder Cancer (NMIBC) is right now. Consider the following topics, which will be discussed in depth later on:
- Patient risk stratification
- Approved agents
- Investigational agents
- Please provide a brief overview of risk stratification for patients with NMIBC and treatment strategy for each group.
- What are the FDA-approved agents for treating patients with NMIBC, and what treatment options are available for BCG-naïve and BCG-unresponsive patients?
- How do intravesical therapies compare to intravenous therapies in this context?
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At a median follow-up of 60.9 months, median EFS was 74.1 months in the pembrolizumab arm and not reached in the placebo arm.
Michael S. Cookson, MD, MMHC, FACS, discusses how Anktiva’s expanded FDA approval may broaden bladder-preserving treatment options for BCG-unresponsive papillary-only NMIBC.
This approval expands the perioperative use of pembrolizumab plus enfortumab vedotin to all patients with MIBC, regardless of cisplatin eligibility.
The agency issued a PDUFA target action date of June 14, 2027.
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.
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