The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted that apaziquone (Qapzola, Spectrum Pharmaceuticals) for immediate intravesical instillation after transurethral resection of bladder tumors has not shown substantial evidence of a treatment effect in patients with non–muscle-invasive bladder cancer.
The panel voted unanimously that apaziquone had no more effect on the disease than placebo during a two-year period.
The committee’s decision is not binding on the FDA, which will make the final determination on whether the treatment merits marketing approval. The Prescription Drug User Fee Act (PDUFA) action date is December 11, 2016.
Apaziquone is inserted directly into the bladder after surgery to remove tumors. The treatment is activated by enzymes that are overexpressed in bladder cancer cells.
In 2012, two late-stage clinical trials failed to meet their primary objectives. Spectrum Pharmaceuticals initiated a new late-stage study, which included pooled data from its two previous trials. The pooled data, as opposed to data from individual studies, showed a reduction in disease recurrence over two years.
The new trial protocol called for patients to be given one or two instillations of the drug or placebo. In the previous late-stage studies, all patients received only one instillation or placebo.