Qapzola
Treatment for Bladder CancerSpectrum Pharmaceuticals Receives Complete Response Letter from FDA for Qapzola
On November 17, 2016, Spectrum Pharmaceuticals, Inc. (the “Company”) received a Complete Response Letter from the U.S. Food and Drug Administration (the “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.
Posted: November 2016
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