Bladder Cancer

Patient goals, disease features, and response to prior therapy guide treatment choices across high-risk NMIBC, according to Suzanne B. Merrill, MD, FACS.

BCG monotherapy and a high-quality TURBT remain the foundation for BCG-naive high-risk NMIBC, according to Vignesh T. Packiam, MD.

Patient priorities and practice logistics should guide therapy selection in BCG-unresponsive NMIBC, according to Katie S. Murray, DO, MS, FACS.

Systemic therapy now anchors MIBC care and expands bladder preservation options, according to Joshua J. Meeks, MD, PhD.

BCG optimization should precede checkpoint inhibitor intensification in BCG-naive high-risk NMIBC, according to Tom Jayram, MD.

The phase 1 study is intended to characterize the safety, tolerability, and feasibility of intravesical administration of UGN-501.

Five-year follow-up data show durable responses with UGN-101 in patients with low-grade upper tract urothelial carcinoma who achieved an initial complete response.

Topline results are expected in November 2026 ahead of a planned sBLA submission.

In a POTOMAC subgroup analysis, durvalumab plus BCG reduced the risk of high-risk recurrence or death by 44% vs BCG alone in patients with papillary-only, BCG-naive NMIBC.

Final phase 3 CA017-078 data show perioperative nivolumab plus GC did not significantly improve pCR (39.1% vs 29.6%) or EFS (HR, 0.94) vs GC alone in MIBC.

Perioperative durvalumab (Imfinzi) plus neoadjuvant enfortumab vedotin-ejfv (Padcev) cut the risk of EFS events by 49% and death by 42% in cisplatin-ineligible MIBC.

At a median follow-up of 60.9 months, median EFS was 74.1 months in the pembrolizumab arm and not reached in the placebo arm.

This approval expands the perioperative use of pembrolizumab plus enfortumab vedotin to all patients with MIBC, regardless of cisplatin eligibility.

The agency issued a PDUFA target action date of June 14, 2027.

Long-term QUILT-3.032 findings show durable responses with Anktiva plus BCG in BCG-unresponsive NMIBC, with an estimated 84.2% cystectomy-free survival at 3 years.

This approval expands the label for nogapendekin alfa inbakicept to include patients with high-grade papillary-only tumors.