Briefing Summary: US FDA Posts Advisory Committee Materials for Telesta Therapeutics’ MCNA for Bladder Cancer – NOV 18, 2015 (CTGTAC-ODAC)

The US FDA has posted details, including company and FDA Briefing Materials, for the Wednesday, November 18, 2015 joint meeting of the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC). The Committees will discuss the safety and efficacy of 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