FDA issues complete response letter for MCNA (urocidin, or Mycobacterium phlei Cell Wall-nucleic acid complex)) in bladder cancer- Telesta
The FDA has issued a Complete Response Letter to Telesta's Biologics License Application for MCNA (Urocidin) in bladder cancer. In this letter, the FDA communicated that an additional Phase III clinical trial for MCNA would be necessary to adequately establish MCNA's efficacy and safety. The FDA also encouraged Telesta to meet with them to discuss further clinical development of MCNA.
Comment: Current treatment for patients who fail BSG immunotherapy is bladder removal of cystectomy- a complex 6-8 hours of surgery followed by 10 days in hospital and an 8% mortality within 6 months of surgery. Cystectomy is associated with 28% to 45% surgical complications.
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