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.
|Videos|August 22, 2022
Dr. Packiam on background of study of sequential intravesical chemo in BCG-naïve NMIBC
Author(s)Urology Times staff
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Vignesh Packiam, MD, explains the background of the study, “Sequential Intravesical Gemcitabine and Docetaxel for bacillus Calmette-Guérin-Naïve High-Risk Nonmuscle-Invasive Bladder Cancer,” which was published in the Journal of Urology. Packiam is a clinical assistant professor of Urology, Department of Urology, University of Iowa Hospitals and Clinics.
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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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