FDA approves mitomycin for low-grade upper tract urothelial cancer

  • FDA
  • 15 Apr 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • The FDA has approved mitomycin for the treatment of adult patients with low-grade upper tract urothelial cancer (UTUC).
  • The recommended dose is 4 mg/mL, instilled via ureteral catheter or nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not exceeding 15 mL.

Why this matters

  • Mitomycin will provide an alternative treatment option for patients with low-grade UTUC who otherwise require nephroureterectomy.

Key highlights

  • The approval was based on an ongoing phase 3 OLYMPUS trial.
  • 71 patients with treatment-naive or recurrent low-grade noninvasive UTUC with ≥1 papillary tumor located above the ureteropelvic junction received mitomycin.
  • Patients who achieved a complete response (CR) at 3 months could receive monthly instillations up to a maximum of 11 additional instillations.
  • At 3 months, 41 patients (58%) achieved a CR.
  • At 12 months after CR determination, 19 patients were still in CR and 7 patients had recurrences.
  • The median duration of CR was not reached (range, 0-18.8+ months). 
  • The most common adverse reactions (≥20%) were ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, fatigue, nausea, abdominal pain, dysuria, and vomiting.

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