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FDA grants fast track designation to MitoGel for upper tract urothelial carcinoma
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The FDA granted fast track designation to MitoGel for the treatment of low-grade upper tract urothelial carcinoma, according to the agent’s manufacturer.
The FDA based its decision in part on results from the ongoing phase 3 OLYMPUS trial.
The single-arm, open-label trial is evaluating the safety, tolerability and tumor ablative effect of MitoGel (UroGen Pharma), which uses a proprietary sustained release, hydrogel-based formulation designed to enable longer exposure of mitomycin C to the urinary tract tissue.
MitoGel is administered via intravesical catheter.
The trial will enroll approximately 70 patients with low-grade upper tract urothelial carcinoma not amendable to endoscopic resection or with contraindication to nephroureterectomy, including impaired renal function.
“Uro-oncology is an area that has seen limited therapeutic innovation over the last several decades,” Arie Belldegrun, MD, chairman of UroGen, said in a company-issued press release. “UroGen’s broad product pipeline, including MitoGel for upper tract urothelial carcinoma, aims to overcome the limitations and deficiencies of currently available treatment options for these cancers. Importantly, fast track designation will help potentially expedite the future regulatory review of MitoGel so we can execute on our goal of bringing this innovative product candidate to market as rapidly as possible.”
Current treatment for upper tract urothelial carcinoma include endoscopic surgical resection of visible cancer, or complete removal of the affected kidney and ureter. However, these approaches are associated with disease recurrence, complications associated with major surgery, and the long-term consequences of decreased renal function.
MitoGel — which previously received orphan drug designation from the FDA — is designed to enable the potential treatment of patients with low-grade upper tract urothelial carcinoma by nonsurgical means.
“MitoGel has the potential to become a first-line treatment for low-grade upper tract urothelial carcinoma sparing patients from invasive surgery as well as the potential risks and complications of kidney removal,” Ron Bentsur, CEO of UroGen, said in the release. “We believe that the FDA’s fast track designation for MitoGel underscores the significant unmet medical need facing upper tract urothelial carcinoma patients, and our goal is to bring MitoGel to this underserved patient population as quickly and efficiently as possible.”