FRIDAY, April 17, 2020 (HealthDay News) -- Jelmyto (mitomycin gel) has been granted approval to treat low-grade upper tract urothelial cancer (UTUC), the U.S. Food and Drug Administration announced Wednesday.
The first therapy specifically for low-grade UTUC, Jelmyto, an alkylating drug, provides an alternative for patients who may otherwise require nephroureterectomy, according to Richard Pazdur, M.D., director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA Center for Drug Evaluation and Research.
Approval was based on clinical trial data from 71 patients with low-grade UTUC. Patients were either treatment-naive or had recurrent low-grade noninvasive UTUC with at least one papillary tumor. They received Jelmyto once a week for six weeks. Those who achieved a complete response then received Jelmyto monthly for up to 11 months. Three months after treatment initiation, researchers evaluated patients' urine cytology, ureteroscopy results, and biopsies, if warranted. Fifty-eight percent of patients had complete response after six weekly treatments. Forty-six percent of those who achieved a complete response continued to have a complete response at one year.
Commonly reported side effects include ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, fatigue, nausea, abdominal pain, dysuria, and vomiting. In 51 percent of patients who had obstruction due to Jelmyto, the obstruction did not resolve or completely resolve. Another potential serious side effect of Jelmyto is urosepsis. The FDA notes that Jelmyto should not be used for patients with a glomerular filtration rate less than 30 mL/minute.
Approval was granted to UroGen Pharma.