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FDA Approves Mitomycin Gel for Upper Tract Urothelial Cancer

The FDA granted approval to UroGen Pharma for mitomycin gel (Jelmyto), the first therapy to treat low-grade upper tract urothelial cancer (UTUC). 

“This is the first approval specifically for patients with low-grade UTUC and provides an option for some patients who may otherwise require a nephroureterectomy,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Due to substantial treatment challenges associated with the complex anatomy of the upper urinary tract, many patients need to be treated with radical surgery – usually complete removal of the affected kidney, ureter and bladder cuff. Jelmyto gives patients, for the first time, an alternative treatment option for low-grade UTUC.”

The approval was based on…

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