FDA Approves UGN-102 For Some With Bladder Cancer

The U.S. Food and Drug Administration has approved UGN-102 (mitomycin intravesical solution) for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

The drug’s efficacy was based on data from the phase 3 ENVISION trial, which evaluated 240 enrolled patients with low-grade NMIBC recurring following previous transurethral resection, or surgical removal, of bladder tumor (TURBT).

Out of 223 evaluable patients, 78% had a complete response, which, in this case, indicates that patients had no cancer left in the bladder according to an internal visual analysis called cystoscopy and a microscope urine evaluation called urine cytology, along with a biopsy if needed. Among those who responded, 79% remained cancer-free for at least one year.

To be part of the study, patients needed to meet at least one of the following: have multiple tumors, have a single tumor larger than 3 cm or have a cancer recurrence within one year.

Side Effects

The most common side effects that patients experienced were pain or burning with urination (dysuria), urinary tract infections, blood in the urine, fatigue and changes in lab values like kidney function or blood counts.

Serious side effects occurred in 12% of patients. Less than 1% of participants experienced urinary retention or urethral narrowing. One patient died from heart failure during the study, although it is not currently public information whether the death was caused by UGN-102.

Additional Evidence From the ATLAS Trial

Previous data from the phase 3 ATLAS trial showed that UGN-102 may also benefit patients regardless of whether they had TURBT. In that study, newly diagnosed patients who received UGN-102 had a 15-month disease-free survival rate of about 77%. Patients with recurrent disease had a 63% disease-free rate over the same period.

Complete response rates remained high at one year in both groups—nearly 88% in newly diagnosed patients and about 69% in those with recurrent cancer.

The most common treatment-related side effects in ATLAS included dysuria, frequent urination, urgent urination, and nighttime urination.

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