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The FDA issued a complete response letter earlier this year regarding a biologics license application for the protein fusion drug in patients with BCG-unresponsive non–muscle invasive bladder cancer.

“I have no doubt that within 10 years…what we've been basing our treatment strategies and surveillance strategies of high-grade…papillary disease is still going to be there. But, in reality, we're really going to have a much better idea of individual risk stratification and characteristics of their tumors,” says Sam S. Chang, MD, MBA.

“We’re not doing enough lymph node dissections in upper tract disease,” says Siv Venkat, MD, FRCSC.

“The take-home message here is that adjuvant nivolumab improves disease-free survival in patients with muscle-invasive urothelial cancer at high risk for recurrence after surgery,” says Matthew D. Galsky, MD.

“It's not a replacement for clinical judgment, obviously. But at the end of the day, the idea is that it shows you what your next steps are based on what the American Urological Association and [Society of Urologic Oncology] guidelines are for non-muscle invasive bladder cancer,” Chad R. Ritch, MD, MBA, FACS.

“We are having a wealth of new medications that are helping our patients. Primarily with advanced disease, but…maybe there are going to be some applications to move that earlier and earlier in the in the disease process,” says Christopher B. Anderson, MD, MPH.

“There's unquestionably a real signal for…agents that are well tolerated that can be given for a long period of time,” says Sam S. Chang, MD, MBA.

“It is a promising drug in terms of the 3-month complete response rate,” says Chad Ritch, MD, MBA, FACS.

Multiple investigational agents have been developed and are being studied.

“We need better tests and better biomarkers to try to determine who still has residual cancer, even though they look like they don't,” says Christopher B. Anderson, MD, MPH.

“Fortunately, since things have…eased up with the pandemic, I would say probably in the last 6 months I've noticed that the BCG availability has improved,” says Chad R. Ritch, MD, MBA, FACS.

"There are going to be more trials open for those patients who may not have received BCG...I think that's essential, to realize that there are other treatments on the horizon for patients with non–muscle-invasive bladder cancer," says Sam S. Chang, MD.

"At the end of the day, the idea is that it shows you what your next steps are based on what the AUA and SUO guidelines are for non–muscle invasive bladder cancer," says Chad R. Ritch, MD, MBA, FACS.

All efficacy-evaluable patients reached a complete response with the combination regimen.

“I wouldn't be surprised if we have spotty distribution areas of concern for the next several years,” says Sam S. Chang MD, MBA, on the latest episode of the UT podcast Speaking of Urology.

"This study provides credible support for the expectation that post-RC HRQOL should recover and improve over the first 2 years after RC, and provides a benchmark for comparisons with future bladder preservation strategies," writes Badar M. Mian, MD.

Neoadjuvant chemotherapy significantly benefited patients with classifier-identified non-luminal tumors.

Data from the phase 2/3 QUILT-3.032 trial showed that adding N-803 to BCG met the primary end point of disease-free survival in patients with BCG-unresponsive, high-grade non–muscle-invasive bladder cancer and papillary disease.

“This is an opportunity for [patients with NMIBC] to have a treatment that is successful and…promising in terms of its durability of responding to the treatment,” says William C. Huang, MD.

“If results of this study are compelling, we may have the opportunity to submit them to the FDA as part of an application for accelerated approval," said Roger Dansey, MD.

Early research has shown the capacity of PVSRIPO to activate a patient's immune system to help trigger a systemic antitumor response.

“In short, there's a ton of missed opportunity to see how smoking affects treatments, especially in trial patients, and even in our patients that are in our clinics,” says Richard Matulewicz, MD, MS.

"The focus of this study and the patient cohort that we're looking at are patients with intermediate-risk bladder cancer who [also have] low-grade bladder cancer. These patients [typically have] a lot of recurrences [and] multi-focal disease but are at low risk of progressing on to metastatic disease or developing invasion into their bladder wall,” says William C. Huang, MD.

The significant treatment response and sustained durability observed in this trial indicate that UGN-102 has the potential to become a nonsurgical alternative for these chronically relapsing patients, who typically undergo repetitive surgeries,” said William C. Huang, MD.

2 recent studies highlighted the continued emergence of liquid biopsies. One study involved bladder cancer and the other involved peripheral nerve tumors, which in rare cases occur in the prostate.






















