FDA, stop sign

The U.S. Food and Drug Administration rejected Sesen Bio’s lead candidate Viceneum (oportuzumab monatox-qqrs) as a treatment for BCG-unresponsive non-muscle invasive bladder cancer.

The U.S. FDA approved Merck & Co. Inc.’s Keytruda for a hard-to-treat form of bladder cancer, making the blockbuster therapy the first new treatment for the cancer in more than two decades.

The Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration voted 9-4 in favor of recommending Merck’s anti-PD-1 therapy Keytruda for the treatment of certain patients with high-risk, non-muscle invasive bladder cancer.