Bladder Cancer

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.

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

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.

At the end of the induction phase, 86% of patients had achieved a complete response.

Two case-based roundtable discussions recently covered the advancing of care for patients with low-grade upper tract urothelial carcinoma.

The observational LOBSTER study has already enrolled 303 patients and collected 479 samples.

“There are a lot of other ways to look at bel-sar with other immunotherapy agents, other combinations, to truly help prevent patients needing to go to the operating room,” says Gary D. Steinberg, MD.

“Now for muscle-invasive [disease], how I counsel patients on surgery when they're a man vs a woman is almost completely different, because their anatomy is very different,” says Ava Saidian, MD.

Anti-tumor activity was observed across all patients with FGFR3-altered metastatic urothelial carcinoma who were treated at the dose levels of 90 mg and higher.

“The other thing that we believe will be important to see is it not only effective where we inject a tumor and turn the light on in the tumor, but will there be abscopal effects throughout the bladder?” says Gary D. Steinberg, MD.

“I think one of the biggest challenges women have in general in terms of diagnosis of bladder cancer is that it tends to be delayed,” says Ava Saidian, MD.