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FDA Grants Priority Review to BLA for Vicineum for Treatment of High-Risk, BCG-Unresponsive NMIBC

The FDA has accepted and granted priority review to a biologics license application (BLA) for the locally administered fusion protein Vicineum for the treatment of high-risk, bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC), according to the agent’s developer, Sesen Bio.1

Of note, the FDA indicated it is not currently planning to hold an advisory committee meeting to discuss the BLA. A prescription drug user fee act (PDUFA) target action date of August 18, 2021 has been assigned.

“We have been meeting with the FDA regularly for the past 2 years on the application for Vicineum,” Thomas Cannell, DVM, president and chief executive officer of Sesen Bio, said in a press release. “We understand the FDA’s position and guidance very clearly and have found the review process to be collaborative and engaging. With these critical FDA decisions, we…

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