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# Sesen Bio Rolling BLA for Bladder Cancer Therapy
- URL: https://www.fdaweb.com/sesen-bio-rolling-bla-for-bladder-cancer-therapy/
- Published: 2019-12-09T12:00:00.000Z
- Updated: 2026-09-14T15:55:53.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5145684

Sesen Bio has begun a rolling BLA for vicinium for treating BCG-unresponsive non-muscle invasive bladder cancer. The company says it has submitted completed non-clinical and clinical modules, and a partially completed Chemistry, Manufacturing and Controls (CMC) module. It expects to complete the BLA submission with the finalization of the CMC module in 2020, and it will requeest a priority review. Vicinium was granted a fast-track designation in 2018.

Vicinium is described by the company as a locally-administered fusion protein. It comprises a recombinant fusion protein that “targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, *Pseudomonas Exotoxin A*,” it says.