Posted by Michael Wonder on 09 Dec 2019
Sesen Bio initiates rolling submission of BLA for Vicinium to FDA
9 December 2019 - --Sesen Bio today announced that on 6 December 2019, the Company initiated the submission of its biologics license application for Vicinium for the treatment of BCG-unresponsive non-muscle invasive bladder cancer under rolling review to the U.S. FDA.
Vicinium was granted fast track designation by the FDA in 2018.
The Company has submitted completed non-clinical and clinical modules, and a partially completed Chemistry, Manufacturing and Controls (CMC) module. The Company anticipates completing the submission with the finalisation of the CMC module in 2020. If the FDA accepts the filing, the Company plans to request a priority review.
