Background Analysis: US FDA Advisory Committees to Review Telesta Therapeutics’ MCNA for Bladder Cancer – NOV 18, 2015 (CTGTAC-ODAC)

The U.S. FDA has scheduled a joint meeting of the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and Oncologic Drugs Advisory Committee (ODAC) for Wednesday, November 18, 2015. The Committees will discuss the safety and efficacy of a Biologics License Application (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.

See the SAC Tracker report