Critical Unmet Needs for Patients with MIBC and Ongoing Clinical Trials in the Neoadjuvant Setting

If approved, durvalumab will be the first and only perioperative immunotherapy regimen available for the treatment of patients with muscle-invasive bladder cancer in this curative-intent setting.

In an interview, Antoni Vilaseca Cabo, MD, discussed the clinical activity of TAR-210 in patients with non-muscle invasive bladder cancer.

The FDA is currently evaluating the application of intravesical mitomycin for low-grade intermediate-risk non–muscle-invasive bladder cancer.

TYRA-300 showed promising safety and preliminary antitumor activity in FGFR3-altered metastatic urothelial cancer, with a 54.5% partial response rate and 100% disease control in the SURF301 trial.

Gilead, manufacturer of the TROP2-directed antibody-drug conjugate sacituzumab govitecan, made the decision to withdraw the agent in consultation with the FDA.

A Prescription Drug User Fee Act target action date of June 13, 2025, has been set for the new drug application of intravesical mitomycin.