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Qapzola Approval Status

  • FDA approved: No
  • Brand name: Qapzola
  • Generic name: apaziquone
  • Company: Spectrum Pharmaceuticals, Inc.
  • Treatment for: Bladder Cancer

Qapzola (apaziquone) is an indolequinone bioreductive prodrug and analog of mitomycin C for intravesical instillation in the treatment of non-muscle invasive bladder cancer.

On November 17, 2016, Spectrum Pharmaceuticals, Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) with respect to the Company’s New Drug Application for Qapzola (apaziquone for intravesical instillation). On November 15, 2016, the Company met with the FDA to discuss the strategy for further development of Qapzola. Based on the discussions, the Company is evaluating a new smaller study that would replace the ongoing Phase 3 program in which enrollment has been stopped.

Development Status and FDA Approval Process for Qapzola

DateArticle
Nov 17, 2016Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for Qapzola
Sep 14, 2016FDA Advisory Committee Votes that Qapzola (apaziquone) Has Not Shown Substantial Evidence of a Treatment Effect Over Placebo
Feb 19, 2016Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for EOquin (apaziquone for intravesical instillation)
Oct 26, 2015Spectrum Pharmaceuticals Initiates Apaziquone Pivotal Trial for the Treatment of Non-Muscle Invasive Bladder Cancer (NMIBC) Following SPA Agreement
Apr  5, 2012Spectrum Pharmaceuticals Announces Results of Apaziquone Phase 3 Clinical Trials

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