FDA advisory committee recommends Urocidin/MCNA (Mycobacterium phlei Cell Wall-nucleic acid complex) for bladder cancer- Telesta Therapeutics

Telesta Therapeutics announced results of the FDA Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee held on November 18, 2015 to discuss the safety and efficacy of Telesta's Biologics License Application (BLA) for MCNA otherwise known as Urocidin (Mycobacterium phlei Cell Wall-nucleic acid complex). The Advisory Committee voted 18 no to 6 yes, with no abstentions, on the following question: "Does MCNA have an overall favorable benefit-risk profile for the treatment of non-muscle invasive bladder cancer at high risk of recurrence or progression in adult patients who failed prior BCG immunotherapy, e.g., in patients who are BCG-refractory or BCG-relapsing?"

The FDA is not bound by the Advisory Committee's recommendation but does takes its advice into consideration when considering the approval of a new therapeutic. The FDA's Prescription Drug User Fee Act (PDUFA) review goal date for MCNA is February 27, 2016.

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.