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ODAC: Qapzola does not effectively treat nonmuscle-invasive bladder cancer
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An FDA advisory panel voted unanimously that apaziquone for immediate intravesical instillation post-transurethral resection of bladder tumors does not improve outcomes compared with placebo in patients with nonmuscle-invasive bladder cancer, according to a press release from the agent’s manufacturer.
Apaziquone (Qapzola, Spectrum Pharmaceuticals) was evaluated in two multicenter, randomized phase 3 trials, in which patients with low-risk, nonmuscle-invasive bladder cancer received a single dose of the agent in their tumor immediately following surgery. Both trials failed to achieve their primary endpoint of improvement in tumor recurrence rate at 2 years compared with placebo.
The agent was subsequently evaluated in a late-stage trial that was designed based on recommendations from the FDA.
The FDA, which is not obligated to follow ODAC’s recommendation, is expected to make its decision on apaziquone by Dec. 11.