Bladder Cancer

“If patients are not experiencing a clear clinical benefit for chemotherapy prior to surgery, we need to be really thoughtful about how we use it,” says Fed Ghali, MD.

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.

“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.

"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.

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

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.

“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.

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.

The priority review decision is based on results of the phase 3 NIAGARA study (NCT03732677).

Ferring has announced the opening of the first clinical trial sites for 2 studies within the ABLE clinical trial program as well as the launch of the phase 1/2 LUNAR trial.

“The combination of pembrolizumab and chemotherapy presents a promising new treatment approach for these challenging-to-treat, rare cancers and could be a major breakthrough for patient care,” says Arnold I. Chin, MD, PhD.

“The median DOR of 47.8 months in patients who achieved complete response with JELMYTO provides evidence of robust durability in maintaining control of low-grade UTUC over an extended period,” says Phillip Pierorazio, MD.

“I think as urologists, we need to become more comfortable with the female pelvic floor,” says Ava Saidian, MD.

At the time of data cutoff, 71% of patients achieved a complete response following treatment.

"We only have so much time with our patients, but we want to show them that we support them," says Ava Saidian, MD.

"Together, the data point to the exciting potential for this combination regimen to be used to treat patients with muscle invasive bladder cancer," says Roger Li, MD.