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"From a usage perspective, it's going to be very easy for urologists or even for labs to transition from urine cytology over to using Oncuria because it's the same practice," says Dave Mori.

The approval is based on data from the phase 3 CheckMate-901 trial, which demonstrated improved overall survival and progression-free survival with the nivolumab-combination therapy vs cisplatin/gemcitabine alone.

Data showed that the combination of EV and pembrolizumab extended overall survival and progression-free survival vs chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

The CMS payment rate for the tests went into effect on January 1, 2024.

In this interview, Mark D. Tyson, MD, MPH, discusses TAR-200 and other novel investigational treatments for non–muscle-invasive bladder cancer.

"Cretostimogene is a novel therapy which has the potential to be a paradigm shift in how we might manage the ongoing burden of this highly recurrent aspect of bladder cancer,” says Neal D. Shore, MD, FACS.

Adjuvant chemotherapy after nephroureterectomy continued to show an efficacy benefit versus surveillance in patients with upper tract urothelial cancer, according to long-term follow-up data from the phase 3 randomized POUT trial.

The sNDA, which was submitted in January 2024, is supported by findings from the phase 3 EV-302 trial.

A personalized patient genetic index will be created to show the presence of bladder cancer as well as evaluate patient response to BCG immunotherapy,” says Marvin S. Hausman, MD.

"Based on the LEA and S1011 trials, it has become clear that patients do not benefit from an extended LND, and a standard bilateral pelvic LND is the standard of care," write Amir Soltani-Tehrani, MD, and Kamal S. Pohar, MD.

"An alternative off-label option for patients with BCG-unresponsive NMIBC is sequential intravesical gemcitabine and docetaxel (Gem/Doce)," write Rachel Passarelli, MD, and Vignesh T. Packiam, MD.

“Our data showed a considerable gap in reporting patient-reported outcomes and in the quality of design and conduct of patient-reported outcomes-related trial endpoints," said Jad Chahoud, MD, MPH.

ZH9 is a proprietary bacterial immunotherapy administered to patients via a single-dose intravesical induction regimen.

"The data from the QUILT 3.032 Quality of Life study suggest that many patients not only have a durable response but also report no decline in physical function, which is very important for these patients,” says Karim Chamie, MD.

The applications in the EU and Japan are both based on findings from the phase 3 EV-302 trial.

"I predict 2024 will be a banner year for progress in the management of [NMIBC], and not only will we be moving the needle but also turning up the volume in this historically quiet space," writes Michael S. Cookson, MD, MMHC, FACS.

The application is based on findings from the phase 2 DESTINY-PanTumor02 trial.

Conversely, investigators noted that there was an overall survival benefit when dose-dense MVAC was used in the neoadjuvant setting.

The approval is based on results from the phase 3 THOR trial.

A phase 3 study is expected to initiate in 2024 to explore the safety and efficacy of UGN-103 in LG-IR-NMIBC.

The mHealth mobile app provides patients with incremental education on post-cystectomy recovery, delivering information at various timepoints after the patient is discharged from the hospital.

“These [patient-reported outcome] data are supportive of the use of [enfortumab vedotin plus pembrolizumab] as a 1L therapy option for patients who are cisplatin-ineligible," write the authors.

Nadofaragene firadenovec received FDA approval in December 2022 for the treatment of patients with high-risk BCG-unresponsive NMIBC with carcinoma in situ with or without papillary tumors.

In total, the study plans to enroll approximately 100 BCG-unresponsive NMIBC CIS patients across 15 clinical study sites in the US and Canada.

Previously reported data showed promising efficacy signals and a manageable safety profile for the combination in patients with advanced solid tumors.

"When we think about a typical procedure for performing a radical cystectomy for cancer with an ileal conduit, that would typically involve lymph node dissection, and therefore CPT 51595 would be best chosen to report that combined procedure," write Jonathan Rubenstein, MD, and Mark Painter.

Data from the EV-302 trial showed a doubling of progression-free survival and overall survival with the ADC/checkpoint combination versus standard chemotherapy.

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

"The Bladder CARE Assay's quantitative nature sets it apart from other tests," said Siamak Daneshmand, MD.

The approval is supported by findings from the phase 3 EV-302 trial, which showed that the combination led to significant improvements in overall survival and progression-free survival compared with chemotherapy.