The FDA approved UroGen Pharma’s (NASDAQ:URGN) mitomycin gel for the treatment of low-grade upper tract urothelial cancer (UTUC).
The gel, which will be marketed under the brand name Jelmyto, inhibits DNA transcription into RNA, stopping protein synthesis so cancer cells are unable to multiply.
The approval was based on Urogen’s Phase 3 UTUC trial, which had a primary endpoint of complete response at three months following initiation of therapy. A complete response was found 58% of patients following six treatments of Jelmyto, administered weekly. At 12 months, 46% of patients continued to have a complete response.
“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,” Dr. Richard Pazdur, 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 statement.
“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,” he added.
