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
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