Sesen Bio Initiates Rolling Submission of BLA for Vicinium to FDA for the treatment of BCG-unresponsive non-muscle invasive bladder cancer

Dec  09, 2019: Sesen Bio announced that on December 6, 2019, the Company initiated the submission of its Biologics License Application (BLA) for Vicinium for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) beneath Rolling Review to the U.S. Food and Drug Administration (FDA).

The initiation of the rolling BLA for Vicinium marks a tremendous achievement for Sesen Bio, to help save and renew the lives of patients with cancer.

The Company anticipates completing the BLA submission with the completion of the CMC module in 2020. If BLA filing accepted by FDA, the Company plans to request a Priority Review.

https://ir.sesenbio.com/news-releases/news-release-details/sesen-bio-initiates-rolling-submission-bla-vicinium-fda