A new drug application has been submitted to the FDA for UGN-102, an intravesical solution for treating low-grade, intermediate-risk non–muscle-invasive bladder cancer.
An NDA seeking the approval of UGN-102 for intravesical solution has been submitted to the FDA for the potential treatment of patients with low-grade, intermediate-risk NMIBC.1
A decision regarding potential approval from the FDA in early 2025 is expected, as long as the NDA is accepted for filing by the regulatory agency and is granted priority review.
Data from the UGN-102 clinical program, including the phase 3 ENVISION trial, support this NDA. In the ENVISION study, UGN-102 led to a 79.6% (95% CI, 73.9%-84.5%) complete response (CR) rate at 3 months after the first instillation in patients with low-grade, intermediate-risk NMIBC.1,2 With the agent, the estimated 12-month duration of response (DOR) rate was 82.3% (95% CI, 75.9%-87.1%) in the 108 patients who had a CR at 3 months. Further, the estimated DOR rates at 15 (n = 43) and 18 months (n = 9) among those who achieved a CR at 3 months were both 80.9% (95% CI, 73.9%-86.2%).2
“The completion of the NDA submission for UGN-102 marks a crucial milestone for UroGen and underscores our dedication to advancing this groundbreaking treatment for patients with low-grade, intermediate-risk NMIBC,” said Liz Barrett, president and chief executive officer of UroGen, in a press release.1 “By providing a viable alternative to repeated surgeries, if approved, UGN-102 may offer patients quality-of-life benefits and clinically meaningful recurrence-free intervals. The high recurrence rates associated with low-grade, intermediate-risk NMIBC make the need for innovative therapies like UGN-102 urgent. UGN-102 could become a valuable new option for managing this challenging disease.”
Looking at safety, the safety profile of UGN-102 was similar in the ENVISION trial to that observed in other studies. In ENVISION, the most common treatment-emergent adverse events (TEAEs) included hematuria, dysuria, pollakiuria, urinary tract infection, urinary retention, and fatigue, and most of these were mild to moderate, resolved, or were resolving.2
Bladder cancer stages: © pikovit - stock.adobe.com
ENVISION is a single-arm, multicenter, international trial evaluating UGN-102 in patients with low-grade, intermediate-risk NMIBC.3 Patients enrolled in the study were required to have low-grade NMIBC that was histologically confirmed by cold cup biopsy at screening or within 8 weeks before screening. A history of a previous episode of low-grade NMIBC requiring treatment with transurethral resection of bladder tumors, negative voiding cytology for high-grade disease within 8 weeks before screening, and an anticipated life expectancy of at least the trial duration were all requirements for enrollment in the study.
Patients were also required to have intermediate-risk disease, defined as having 1 or 2 of the following: the presence of multiple tumors, a solitary tumor of at least 3 cm, or early or frequent recurrence.
Once enrolled, patients were given 6 once-weekly UGN-102 instillations. The study’s primary end point is CR rate, and secondary end points consist of DOR, durable CR rate, disease-free survival, and incidence of TEAEs.
FDA Grants Zongertinib Breakthrough Therapy Designation in HER2-Mutant NSCLC
August 27th 2024New data on zongertinib for HER2-positive non–small cell lung cancer will be presented at the IASLC 2024 World Conference on Lung Cancer, shedding light on its potential as a novel treatment option for this patient population.
Read More