FDA granted priority review for MCNA, developed by Telesta Therapeutics Inc.
The FDA completed its initial review of Telesta’s biologics license application and accepted it for filing. The agency set Feb. 27, 2016 as the review goal date for MCNA. The FDA has also advised that it will be organizing an advisory committee to discuss the BLA application.
MCNA is a biologic therapy developed to treat high-risk, non-muscle invasive bladder cancer patients who are refractory to or relapsing from front-line therapy, and is derived from the cell wall fractionation of a non-pathogenic bacteria. Its activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects.
MCNA was developed to be delivered as a sterile suspension for intravesical administration by urologists and urology nurses, following the same dosing paradigm as first-line bacillus Calmette-Guérin therapy. The efficacy, duration of responses and safety data from MCNA’s phase III trial was recently published in The Journal of Urology.
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