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Vicineum FDA Approval Status

Last updated by Judith Stewart, BPharm on Aug 5, 2021.

FDA Approved: No
Brand name: Vicineum
Generic name: oportuzumab monatox-qqrs
Company: Sesen Bio
Treatment for: Bladder Cancer

Vicineum (oportuzumab monatox-qqrs) is a locally administered fusion protein in development for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

Development timeline for Vicineum

Aug 13, 2021Sesen Bio Receives Complete Response Letter from FDA for Vicineum (oportuzumab monatox-qqrs)
Feb 16, 2021Sesen Bio Announces FDA Acceptance and Priority Review of its Biologics License Application for Vicineum
Dec 21, 2020Sesen Bio Submits Completed Biologics License Application to the FDA for Vicineum and Has Requested Priority Review

Further information

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