FDA rejects Viceneum (oportuzumab monatox-qqrs) as a treatment for BCG-unresponsive non-muscle invasive bladder cancer

FDA said it is unable to approve Biologics License Application in present form for this agent that binds specifically to EpCAM receptors expressed on bladder cancer cells where it delivers cytotoxic Pseudomonas Exotoxin A. Additional clinical & statistical data analyses needed.

SPS commentary:

In March 2021, a Marketing Authorization Application was submitted in the EU for oportuzumab monatox for the treatment of high-risk BCG-unresponsive non-muscle invasive bladder cancer.

Biospace Inc.