FDA grants priority review to UGN-101 for upper tract urothelial cancer
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The FDA granted priority review to UGN-101 as a potential treatment for patients with low-grade upper tract urothelial cancer, the agent’s manufacturer announced in a press release.
If approved, it would be the first nonsurgical therapy for this patient population.
UGN-101 (UroGen Pharma) — an investigational drug formulation of mitomycin — is delivered via standard intravesical catheters.
The sustained release, hydrogel-based formulation is intended to allow for longer exposure of mitomycin to the urinary tract tissue, enabling treatment of tumors by means other than surgery.
The new drug application for UGN-101 is based on results of the phase 3 OLYMPUS trial, which showed 59% of patients achieved complete response. Most responses lasted 6 months (89%) and 12 months (84%). Estimated median time to recurrence was 13 months.
The most frequently reported treatment-emergent adverse events included ureteric stenosis (43.7%), urinary tract infection (32.4%), hematuria (31%), flank pain (29.6%), nausea (23.9%), dysuria (21.1%), renal impairment (19.7%) and vomiting (19.7%). Most of these events were mild to moderate; however, 8.5% of patients experienced severe ureteric stenosis events.
“The FDA filing acceptance and granting of priority review for UGN-101 is an important milestone in our mission to pioneer new treatments to improve patient care in specialty cancers and urologic diseases,” Liz Barrett, president and CEO of UroGen, said in the release. “There is a significant unmet need for a better treatment option for patients with low-grade upper tract urothelial cancer, as the current standard of care involves surgical removal of the kidney or repetitive endoscopic tumor removal.”
The FDA — which previously granted orphan drug, fast track and breakthrough therapy designations to UGN-101 for this indication — is expected to make a decision on the application by April 18.