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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.

“The impressive duration of response, still expanding with 6/8 responses ongoing, is indicative of restoration of a lasting immunologic tumor control in advanced solid tumor patients,” says Eugen Leo, MD, PhD, MBA

The designations, which will expedite the development and regulatory review of cretostimogene grenadenorepvec in this setting, are supported by results from the phase 3 BOND-003 trial.

The application is based on results from the phase 3 CheckMate-901 trial.

The designation, which will expedite the development and regulatory review of TAR-200 in this setting, is based on findings from the phase 2b SUNRISE-1 trial.

The priority review is based on results from the phase 3 EV-302 trial.

The application is based on results from the phase 3 CheckMate-901 trial.

"If a patient begins treatment with platinum-based chemotherapy and maintenance immune checkpoint inhibition, second-line options may involve evaluating erdafitinib, ADCs, or participation in clinical trials," says Adanma Ayanambakkam, MD.

The FDA has accepted a resubmitted biologics license application for N-803 for use in combination with BCG for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.

"Our data show no evidence of benefit from selenium and evidence of harm from vitamin E—a compound readily available over the counter," the authors write.

An approach combining chemotherapy and immunotherapy could help preserve quality of life.

"If additional research confirms our findings, this may lead to a new paradigm in the treatment of muscle-invasive bladder cancer," says Matthew Galsky, MD.

Treatment with adjuvant pembrolizumab reduced the risk of disease recurrence or death versus observation in patients with localized muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma.

"It is erdafitinib’s time to shine," says Arlene O. Siefker-Radtke, MD.

The EV-302 trial is the confirmatory trial for the FDA’s accelerated approval of pembrolizumab plus enfortumab vedotin for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma.