Sesen Bio (NASDAQ:SESN) has completed a Type B Pre-BLA meeting regarding the approval path for Vicinium for the treatment of patients with Bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC).
The FDA has recommended an Accelerated Approval Pathway along with Rolling Review, and the Company expects to initiate BLA submission in Q4.
The FDA also indicated that no additional clinical trials are necessary for a BLA submission.
Sesen Bio plans to schedule two additional meetings with the FDA in H2 2019, a Type C meeting to discuss the details of a post-marketing confirmatory trial, and a Type B CMC meeting to discuss the submission strategy of the CMC module.
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