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FDA approval sought for UGN-102 for low-grade intermediate-risk NMIBC


UroGen has initiated a rolling submission of an FDA New Drug Application (NDA) for UGN-102 for the treatment of patients with low-grade intermediate-risk non–muscle-invasive bladder cancer (NMIBC).1



The NDA is primarily based on findings from the phase 3 ENVISION trial. Results from the trial have shown that at 3 months’ follow-up, the complete response rate was 79.2% (95% CI, 73.5-84.1) with UGN-102.2

UroGen reported in a press release that 12-month duration of response data from ENVISION are scheduled to be shared with the FDA during the second quarter of this year. The company added that it plans to complete the NDA submission this coming September.1

Overall, the open label single-arm ENVISION trial included 240 patients with low-grade intermediate-risk NMIBC.2 The study defined this disease status as having 1 or 2 of these characteristics:

  • Single tumor larger than 3 cm
  • Multiple tumors
  • Early or frequent recurrence, defined as having at least 1 occurrence of low-grade NMIBC within 12 months of current diagnosis

The median patient age was 70.0 years (range, 30-92), 61% of patients were male, 39% were female, and 99% were White. Ninety-six percent of patients had prior transurethral resection of bladder tumor (TURBT). Overall, 91% of patients had 2 or fewer previous low-grade NMIBC episodes.

Patients received primary chemoablative therapy with UGN-102 as 6 once-weekly intravesical instillations administered using a traditional urethral catheter. “This is primary therapy—patients did not undergo TURBT,” explained Prasad.

Nearly all patients (95%) received the full 6 instillations.

The primary end point was the rate of complete response 3 months after the initial instillation. Secondary outcome measures include duration and durability of response, as well as disease-free survival.

The safety population included all 240 patients. Nearly all treatment-emergent adverse events (TEAEs) were mild or moderate. TEAEs occurring in at least 5% of patients included dysuria (17.9% mild; 3.8% moderate), (hematuria 6.3% mild; 2.1% moderate), pollakiuria (5.4% mild; 0.8% moderate), urinary tract infection (1.7% mild; 4.2% moderate), and fatigue (3.8% mild; 1.7% moderate). One patient had severe dysuria.

ATLAS trial

UGN-102 previously demonstrated efficacy in the phase 3 ATLAS trial. In the study. UGN-102 with or without TURBT was shown to improve outcomes vs TURBT alone in patients with low-grade intermediate-risk NMIBC.3

Compared with TURBT alone, treating patients with primary, non-surgical chemoablation with UGN-102 with or without subsequent TURBT led to a 55% reduction in the risk of recurrence, progression, or death (event-free survival [EFS]). The EFS rate at 15 months was 72% for patients who received UGN-102 with or without TURBT vs 50% for patients treated with TURBT alone (HR, 0.45).

Additionally, at the first disease assessment 3 months following initiation of treatment, the tumor-free complete response rate was 65% (92 of 142 patients ) for those receiving UGN-102 with or without TURBT, compared with 64% (89 of 140 patients) for those receiving TURBT alone.

“The phase 3 ATLAS and ENVISION trials both produced meaningful and unprecedented results underscoring the potential of UGN-102 to fundamentally change the way patients with low-grade intermediate-risk non-muscle invasive bladder cancer are treated,” Liz Barrett, President and CEO of UroGen stated in the press release.1


1. UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102. Published online and accessed March 14, 2024. https://www.businesswire.com/news/home/20240314112098/en

2. Prasad S, Mladenov B, Shishkov D, et al. Primary chemoablation for recurrent low grade intermediate risk (LG IR) NMIBC: the ENVISION trial. Presented at: 2023 Society of Urologic Oncology Annual Meeting. November 28 – December 1, 2023; Washington, DC. LBA 3389.

3. Prasad SM, Huang WC, Shore ND, et al. Treatment of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer with UGN-102 ± Transurethral Resection of Bladder Tumor (TURBT) Compared to TURBT Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS) [published online ahead of print August 7, 2023]. J Urol. doi: 10.1097/JU.0000000000003645

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