A Phase 3, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
Phase of Trial: Phase III
Latest Information Update: 26 Aug 2017
At a glance
- Drugs Mycobacterium cell wall DNA complex (Primary) ; Mitomycin
- Indications Bladder cancer
- Focus Registrational; Therapeutic Use
- Acronyms EMBARC-RF
- Sponsors Endo Pharmaceuticals
- 02 Feb 2016 According to a Telesta Therapeutics media release, the FDA has issued a Complete Response Letter to company's Biologics License Application (BLA) for MCNA. The FDA has communicated that an additional Phase III clinical trial for MCNA would be necessary to adequately establish MCNA's efficacy and safety.
- 28 Aug 2015 According to a Telesta Therapeutics media release, results from this trial were published in The Journal of Urology.
- 28 Aug 2015 According to a Telesta Therapeutics media release, the FDA has completed its initial review of Biologics License Application (BLA) submitted on June 29, 2015 and has accepted it for filing. The FDA has designated the file for 6 month Priority Review and has set February 27, 2016 as the review goal date for MCNA.