Bladder Cancer

The planned sBLA will seek approval of Anktiva for patients with BCG-unresponsive NMIBC in the papillary indication.

The NDA is supported by data from cohort 2 of the phase 2b SunRISe-1 trial.

"I think integrating microbiome surveillance into clinical trials can bridge the gap between research and also therapeutic applications," says Ilaha Isali, MD, MSc.

“In this phase 2 study, an image-guided adaptive strategy enabled radiotherapy dose escalation to over 86% of patients’ bladder tumors without significant increase in toxicity,” wrote the authors.

“It's hard for us, based on our evidence here, to say that neoadjuvant chemotherapy is causal in any way or is resulting in prolonged survival,” says Fed Ghali, MD.

"The increasing expenses associated with bladder cancer treatment highlight wider issues regarding the sustainability of health care expenditures in the US," writes Michael S. Cookson, MD, MMHC, FACS.

Results from CREST will be presented at an upcoming medical conference.

"We expect to initiate patient dosing in the second quarter of this year, with initial three-month [complete response] data to follow," says Doug Warner.

A panelist discusses how emerging investigational agents for NMIBC show promise through diverse mechanisms, including oncolytic viruses (CG0070), immune checkpoint inhibitors (durvalumab, sasanlimab), targeted drug delivery systems (TAR-200), mitomycin-containing gels (UGN-102/103), immunotherapies (TARA-002), gene therapies (EG-70), and FGFR inhibitors (erdafitinib), representing a robust pipeline of potential treatment options.

9MW2821 was previously awarded a breakthrough therapy designation as a monotherapy for locally advanced or metastatic urothelial carcinoma.

"Studying the microbiome overall is challenging because it's dirty science. You have to be incredibly careful with contamination," says Ilaha Isali, MD, MSc, and Laura Bukavina, MD, MPH, MSc.

At a median follow-up of 33.2 months, the confirmed objective response rate was 73.2%.

The NMPA’s approval was supported by data from the phase 3 EV-302 trial.

"The interplay between the microbiome and bladder cancer is very complex," says Ilaha Isali, MD, MSc.

“It's a good problem to have, because we're thinking about a previous era in which we didn't have many options besides more BCG vs cystectomy,” says Vikram M. Narayan, MD.

The J-code became effective on January 1, 2025.

"We're very much looking forward to the new data that'll be presented, hopefully, within the next year, to see where this falls in the grand scheme of the all the new drugs coming into play here," says Shreyas S. Joshi, MD, MPH.

"We...tried to summarize all the findings that could potentially be helpful for future research in terms of bladder cancer," says Ilaha Isali, MD, MSc.

A panelist discusses how recent advances in transurethral resection of bladder tumor (TURBT) include enhanced visualization techniques like fluorescence-guided surgery and narrow-band imaging to improve tumor detection and complete resection, while radical cystectomy remains a critical option for high-risk NMIBC patients who fail conservative therapies.

Catch up on all the notable drug and device approvals in urology over the past year.

“Women not only tend to present with more aggressive disease, but they also have a higher probability of having what we call variant histology, so non-urothelial carcinoma,” says Ava Saidian, MD.

As the year comes to a close, we revisit some of this year’s top content on bladder cancer.

As the year comes to a close, we revisit some of this year’s top video content from Urology Times.

"We're excited about the science behind it, but we're also excited for our patients that if they can have access to this, maybe we can delay or completely avoid radical cystectomy or further aggressive treatments," says Shreyas S. Joshi, MD, MPH.

A panelist discusses how identifying intermediate-risk patients, managing disease heterogeneity in non–muscle-invasive bladder cancer, and addressing long-term care needs present key challenges in patient care while highlighting recent treatment advances that offer promising solutions.