Expert Insight

  • Assistant Professor of Surgery at the Hospital of the University of Pennsylvania, Dr. Leilei Xia views the 2025 approval of Zusduri as meaningful because it shifts intent — from preventing recurrence to actively treating visible, low-grade tumors in the office setting.
  • By offering an alternative to repeat TURBT, he sees the intravesical mitomycin gel as a practical, OR-sparing option that changes how recurrent NMIBC can be managed.

In a move that broadened options for select bladder cancer patients, the FDA last year approved Zusduri for adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

According to Penn Medicine’s Dr. Leilei Xia, this FDA approval of Zusduri, an intravesical mitomycin gel, signals a subtle but important evolution in approach — reframing therapy from an adjunctive strategy to one aimed at actively addressing existing tumors.

Dr. Xia explains that the distinction lies in intent.

Unlike adjuvant therapies, which are given after tumor resection to reduce the risk of recurrence, Zusduri is designed to actively treat visible tumors identified during office cystoscopy.

“This is intended as a treatment, not as an adjuvant therapy,” Dr. Xia says. “If we see a small, recurrent low-grade Ta tumor during office cystoscopy, we don’t necessarily have to bring the patient back to the operating room for another TURBT. We can treat it directly with Mitomycin intravesical gel.”

Historically, recurrent low-grade Ta bladder cancers have required repeat transurethral resections of bladder tumor (TURBT), often subjecting patients to multiple procedures over the course of their disease. With Zusduri, eligible patients may instead receive an office-based intravesical gel that delivers chemotherapy directly to the tumor.

Dr. Xia contrasts this with investigational gene-therapy approaches studied in trials such as PIVOT-006, which are being evaluated in the adjuvant setting — meaning they aim to prevent recurrence after tumor removal. Zusduri, by contrast, treats the recurrence itself.

This is intended as a treatment, not as an adjuvant therapy compared to the cretostimogene in PIVOT-006,” Dr. Xia says. “What that means is if we see any tumor, for example, intermediate risk, recurrent low risk Ta bladder cancer in the office cystoscopy, we don’t go back in to resect. We just give them the intravesical gel mital to treat it.”

For patients with frequently recurring, low-grade disease, this distinction could translate into fewer trips to the operating room — and a more convenient, less invasive management strategy.