As the entire world continues to battle the COVID-19 virus, current research endeavors in so many different areas have inevitably slowed but fortunately, progress in pushing forward completed research provides hope for patients. This quote from the FDA website reinforces this commitment:
"Although our nation’s emphasis is on the need to combat COVID-19, patients with cancer and their unique needs continue to be a top priority for the FDA," said 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. "We continue to expedite oncology product development in this critical time."1
Importantly, after a priority review and breakthrough therapy designation, the US FDA approved mitomycin gel (Jelmyto™) in April 2020. The product, manufactured by UroGen Pharma, Inc., was also granted fast track status as it was designated as a drug that treated a serious medical condition with unmet need. An upcoming UroToday Journal Club presentation will include a discussion of the Lancet Oncology article that provides the single-arm Phase III data that provided the data leading to approval.
Utilizing a known-effective chemotherapy agent (mitomycin C) in a unique patented temperature-sensitive gel formulation for upper tract makes physiologic sense. Mitomycin C has been used for decades in the bladder. A challenge will be introducing to and educating clinicians about a new “way” to treat upper tract urothelial carcinoma. The FDA indication is quite broad—“for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC).”2
As with any medication, excitement co-exists with questions regarding cost, efficacy, side effects, and long-term results. As more experience and long term data are accumulated, the ultimate role for this new intervention will become clearer. As of now, patients benefit from a previously unavailable option that could spare patients multiple endoscopic procedures and/or loss of an upper tract renal unit.
Written by: Sam S. Chang, MD, MBA, Patricia and Rodes Hart Endowed Professor of Urologic Surgery and Oncology, is the Oncology Fellowship Director and Vice-Chair of Urologic Surgery at Vanderbilt University Medical Center.
Disclosures: Dr. Sam S. Chang, MD, MBA has a consulting role with UroGen Pharma
Published Date: May 2020
References:
1. Commissioner, Office of the. “FDA Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer.” FDA, April 15, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-treatment-low-grade-upper-tract-urothelial-cancer.
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211728s000lbl.pdf
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