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HomeLatest Pharma-NewsSesen Bio Initiates Rolling Submission of BLA for Vicinium to FDA for...

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.

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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

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