Bladder Cancer

The sBLA is supported by findings from the phase 3 EV-302 trial, which showed that EV/pembrolizumab extended overall survival and progression-free survival vs platinum-based chemotherapy in patients with advanced urothelial carcinoma.

“The 1 tweak that's different for our model is that the trained urologist is watching the cysto at the same time as the nurse practitioner is doing it,” says Tracey L. Krupski, MD.

The application for UGN-102 for low-grade intermediate-risk non–muscle-invasive bladder cancer is based on findings from the phase 3 ENVISION trial.

"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.

“With 2 years of follow-up, we saw that there was no difference in these 2 groups in terms of overall survival, metastasis-free survival, or recurrence-free survival,” says Saum B. Ghodoussipour, MD.

"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.

“We’re in a very exciting time for those of us who take care of patients with bladder cancer. There are a lot of new emerging treatment options,” says Vikram M. Narayan, MD.

“We wanted to do a modeling analysis using patient-level data to see if we can estimate whether or not there is a long-term cure or overall survival benefit for these patients,” says Daniel M. Geynisman, MD.

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

“We looked at MRD negative patients, MRD positive patients, and their ultimate clinical response to see if it could be predictive of recurrence-free survival,” says Vikram M. Narayan, MD.

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.

"Real-world data has a real place in demonstrating some of these findings and allowing us to ask better questions," says Bogdana Schmidt, MD, MPH.

"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 gemcitabine/docetaxel [combination] has been the answer that many people have needed,” says Joshua J. Meeks, MD, PhD.

"There's just a lot of active trials being studied, and hopefully, in the next 5 or 10 years, we'll see another handful of agents get approved and really start to make some headway in [NMIBC]," says Alexander I. Sankin, MD.

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