All News

The NDA for UGN-102 is primarily supported by findings from the phase 3 ENVISION trial.

Patient recruitment for the phase 2 trial is expected to begin by the end of 2024.

With this designation, the development process for 9MW2821 can benefit from prioritized engagement with China’s Center for Drug Evaluation as well as expedited review and approval.

"One of the main conclusions that we can take from our study is that although the current classification systems are somewhat accurate, they are far from being perfect," says Félix Guerrero-Ramos, MD, PhD, FEBU.

The CHMP’s positive recommendation is based on findings from the first interim analysis of the phase 3 EV-302 trial.

"In the last decade, we've observed a high number of new alternatives within clinical trials, especially with intravesical delivery," says Félix Guerrero-Ramos, MD, PhD, FEBU.

There was an overall response rate of 39% among the 18 evaluable patients, including 1 complete response and 6 partial responses.

“The MAT2A-Trop2 ADC combination targets 2 distinct, yet complementary nodes in patients with MTAP-deleted urothelial cancer and has first-in-class potential to improve clinical outcomes for bladder cancer patients with poor prognosis associated with MTAP-deletion," says Darrin M. Beaupre, MD, PhD.

“These NIAGARA data show for the first time that adding durvalumab to chemotherapy before surgery followed by durvalumab extends patients’ lives," says Thomas Powles, MD.

Subcutaneous nivolumab is also under review in the United States based on findings from the phase 3 CheckMate-67T trial.

N-803 was approved by the FDA in April 2024 for the treatment of patients with BCG-unresponsive NMIBC carcinoma in situ with or without papillary tumors.

Cretostimogene grenadenorepvec is an intravesical oncolytic immunotherapy currently under investigation in phase 3 trials.

The 12-month duration of response was 82.3% among patients with LG-IR-NMIBC who achieved a complete response at 3 months following the first UGN-102 instillation.

“CORE-001’s excellent efficacy, long-term durability of response, and favorable benefit-to-risk-ratio profile seen with combination cretostimogene and pembrolizumab suggest the potential for a novel bladder-sparing therapy in the BCG-unresponsive NMIBC setting,” said Roger Li, MD.

Gilead reported that a numerical improvement in OS favoring sacituzumab govitecan was observed, though the end point was not reached in the intent-to-treat population.

The approval is based on findings from the phase 3 CheckMate-901 study.

"In [bladder cancer], many women's diagnosis is delayed because their hematuria or microscopic hematuria is blamed on urinary tract infections rather than cancer," says Amy Luckenbaugh, MD.

RAG-01 is an saRNA therapy that is delivered via intravesical instillation and is designed to target and activate p21, a tumor suppressor gene.

The clearance of the IND application for RAG-01 will initiate the launch of clinical trials in the US.

A decision regarding EU marketing authorization is expected by June 2024.

"And [3 out of 5] of those patients who were initially deemed to go on to nephroureterectomy were able to be converted to endoscopic management," says Surena F. Matin, MD.

The approval is supported by findings of the ongoing QUILT-3.032 trial, assessing nogapendekin alfa inbakicept (N-803) plus BCG in patients with BCG-unresponsive non–muscle-invasive bladder cancer.

The 3 new additional studies are the ABLE-22, ABLE-32, and ABLE-42 clinical trials.

The IND will initiate the launch of a phase 3 study to explore the safety and efficacy of UGN-103 in patients with low-grade, intermediate-risk NMIBC.

"This encouraging anti-tumor activity coupled with a favorable safety profile and mode of administration that is both convenient and familiar to urologists indicates that, if confirmed in future studies, TARA-002 could potentially play a meaningful role in NMIBC treatment in the future," says Timothy D. Lyon, MD.

Overall survival was 100% at 12 months and 98% at 18 months among patients with MIBC who remained ctDNA-negative on serial monitoring.

"In this follow-up analysis of the phase 3 study, we demonstrated a sustained response to Adstiladrin treatment over 3 years, allowing more than half of the patients in the study to remain cystectomy free for at least 36 months,” says Colin P.N. Dinney, MD.

"Our study showed that regardless of race, BLC increases the detection of bladder cancer when combined with WLC," says Sia Daneshmand, MD.

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