Derived from the cell wall fractionation of non-pathogenic bacteria, MCNA is a biologic therapy developed to provide high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy with a therapeutic alternative to surgery.
The notification indicates that the FDA has completed its initial review of the BLA submitted in June and has accepted it for filing.
The FDA has also designated the file for six month Priority Review and has set 27 February 2016 as the review goal date for MCNA.
An advisory committee will also be set up by the FDA in order to discuss the BLA application.
Telesta chief executive officer and chief scientist Dr Michael Berendt said: "Today is a historic day for Telesta Therapeutics and for all of our staff and collaborators who have worked so diligently to advance our new treatment for non-muscle invasive bladder cancer towards potential regulatory approval early next year.
"While we recognize that the FDA must complete its full review of our BLA filing before rendering its ultimate decision, we are working extremely hard, at all levels, to prepare for commercial launch in the US."
MCNA’s activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects.
It 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 (BCG) therapy.