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

Trial Profile

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

Discontinued
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
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top