The US Food and Drug Administration (FDA) has approved UroGen Pharma’s Zusduri (mitomycin intravesical solution) to treat a subset of bladder cancer patients.
Zusduri, which is delivered directly into the bladder in an out-patient procedure, is now the first and only medication approved by the US regulator to treat adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
UroGen’s president and chief executive officer, Liz Barrett, said the approval “represents a significant step forward for [the] company and for the treatment of recurrent LG-IR-NMIBC”.
“For the first time,… US patients facing recurrent LG-IR-NMIBC each year have access to an FDA-approved medicine,” Barrett said.
LG-IR-NMIBC patients typically undergo a surgical procedure under general anaesthesia called transurethral resection of bladder tumour (TURBT). This may need to be repeated due to high recurrence rates, with around 59,000 LG-IR-NMIBC patients experiencing recurrent disease in the US every year.
The FDA’s decision on UroGen’s drug was supported by positive results from the phase 3 ENVISION trial, in which Zusduri delivered a 78% complete response for patients at three months, with 79% of these patients still event-free 12 months later.
“For decades, TURBT has been the standard approach for bladder cancer treatment,” said principal investigator of the ENVISION trial, Sandip Prasad. “That’s why innovative treatments like Zusduri are essential, especially for those adult patients with recurrent LG-IR-NMIBC.”
