On Wednesday, November 18, 2015, the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) did not support, by a vote of 6-Yes to 18-No, with no abstentions, the safety and efficacy of (BLA) 125593 for Mycobacterium phlei Cell wall-Nucleic Acid complex (MCNA), submitted by Telesta Therapeutics Inc. (Telesta). The proposed indication is treatment of non-muscle invasive bladder cancer (NMIBC) at high risk of recurrence or progression in adult patients who failed prior Bacillus Calmette-Guérin (BCG) immunotherapy, e.g., in patients who are BCG-refractory or BCG-relapsing.
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Earlier Event: November 13Vaccines and Related Biological Product Advisory Committee
Later Event: November 19Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC)