Mitomycins

Incidence of squamous cell anal carcinoma (SCAC) is rising; ASCO's 2024 guideline recommends concurrent chemoradiation with mitomycin-C and 5-fluorouracil or capecitabine. Retifanlimab, a checkpoint inhibitor, showed improved progression-free survival and overall survival in phase 3 trials, potentially becoming a new standard of care for SCAC. SCAC, primarily HPV-driven, remains a significant unmet medical need with no FDA-approved treatments for advanced disease.

UroGen Pharma reports long-term follow-up study outcomes of JELMYTO (mitomycin) for pyelocalyceal solution, treating low-grade, upper tract urothelial cancer (LG-UTUC) in adults. 41 of 71 subjects achieved complete response, with median duration of response at 47.8 months. The JELMYTO uTRACT Registry is enrolling subjects to gather real-world data. 191 patients have been enrolled across 19 sites as of July 10.

TAR-210, an erdafitinib intravesical delivery system, showed early clinical activity in patients with FGFR-altered high- and intermediate-risk NMIBC. The 12-month recurrence-free survival rate was 90% in high-risk NMIBC patients, with only 2 recurrences out of 21. In intermediate-risk NMIBC patients, the 12-week complete response rate was 90%, with 86% of these responses ongoing at data cutoff. The system aims to reduce systemic toxicities while maintaining efficacy.

Urogen Pharma reported Q3 2024 earnings, with FDA acceptance of UGN-102 NDA for non-muscle invasive bladder cancer, preparing for a 2025 launch. JELMYTO net sales rose to $25.2M, and $254.2M in cash/securities. Initiated Phase 3 trial for UGN-103 and received a patent allowance. Net loss of $23.7M due to increased R&D/administrative expenses. New CFO appointed, focusing on UGN-102 approval and $5B market opportunity.

UroGen Pharma announces Q3 2024 financial results, including $25.2M in JELMYTO net product sales. The FDA accepted the New Drug Application for UGN-102 with a PDUFA target action date of June 13, 2025. UroGen reported $254.2M in cash, cash equivalents, and marketable securities as of September 30, 2024. A conference call and webcast will be held on November 6, 2024, at 10:00 AM ET.

The article discusses the treatment of RK-induced corneal irregularity using the CREATE Protocol, which combines topographic guided ablation with epithelial compensation removal. The study reports a 69% reduction in higher-order aberrations and an 80.2% reduction in grouped aberrations, with 95% of patients achieving 20/40 vision or better post-operatively.

A randomized phase II trial compared single-dose intravesical gemcitabine vs. mitomycin-C post-NMIBC resection, showing comparable recurrence rates, time to recurrence, and adverse effects. No recurrences in low-risk groups, comparable rates in intermediate and high-risk groups. Further follow-up needed for stronger results.