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"The focus of this study and the patient cohort that we're looking at are patients with intermediate-risk bladder cancer who [also have] low-grade bladder cancer. These patients [typically have] a lot of recurrences [and] multi-focal disease but are at low risk of progressing on to metastatic disease or developing invasion into their bladder wall,” says William C. Huang, MD.

The significant treatment response and sustained durability observed in this trial indicate that UGN-102 has the potential to become a nonsurgical alternative for these chronically relapsing patients, who typically undergo repetitive surgeries,” said William C. Huang, MD.

“The purpose of [Cxbladder] Resolve is to identify not only those patients who are at higher risk for urothelial or urinary tract cancer, but those that have a high probability of an aggressive cancer, such as high-grade TA, carcinoma in situ, or T1 to T3,” says Jay Raman, MD, FACS.

In a news release, Checkmate -274 primary investigator Matthew Galsky, MD, hailed the approval as a “major milestone for patients who have undergone major surgery to remove the bladder or parts of the urinary tract and are in need of additional treatment approaches that can help reduce the risk of their UC returning."