Sesen Bio today announced that it received a complete response letter from the U.S. FDA regarding its biologics license application for Vicineum (oportuzumab monatox-qqrs) for the treatment of BCG unresponsive non-muscle invasive bladder cancer.

The FDA has determined that it cannot approve the biologics license application for Vicineum in its present form and has provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls issues pertaining to a recent pre-approval inspection and product quality.

Read Sesen Bio press release