Telesta Therapeutics announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter to the Biologics License Application (BLA) for MCNA in the treatment of non-muscle invasive bladder cancer (NMIBC).
The letter included a request from the FDA for an additional Phase 3 clinical trial for MCNA in order to adequately establish its efficacy and safety in the treatment of NMIBC. The FDA also encouraged Telesta to meet with them to discuss further clinical development of MCNA.
MCNA is a biologic therapy derived from the cell wall fractionation of a non-pathogenic bacteria. It is under investigation for the treatment of NMIBC in patients who are refractory to or relapsing from first line therapy with bacillus Calmette-Guérin (BCG), with a therapeutic alternative to surgery.
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