Vicineum filed with EU for non-muscle invasive bladder cancer.- Sesen Bio

Sesen Bio announced that the Company has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Vicineum (oportuzumab monatox) for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) under the EMA’s centralized procedure. The MAA is supported by the pivotal Phase III VISTA trial data, which the Company believes demonstrates a strong risk-benefit profile. In addition, the Company believes the chemistry, manufacturing and controls (CMC) data confirms the analytical comparability between clinical and commercial supply. On 16 February 2021 Sesen Bio had announced that the FDA accepted for filing the Company’s Biologics License Application (BLA) for Vicineum for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), and granted the application Priority Review and a PDUFA date of 16 August 2021.