FDA Committee Says Bladder Cancer Drug Lacks Substantial Efficacy Evidence
Spectrum announced that the Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted that Qapzola (apaziquone) has not shown substantial evidence of a treatment effect vs. placebo for immediate intravesical instillation post-transurethral resection of bladder tumors (post-TURBT) in patients with non-muscle invasive bladder cancer.
Qapzola is administered via instillation directly into the bladder. Apaziquone, a novel bio-reductive agent, is activated by reductase enzymes such as DT-diaphorase. DT-diaphorase is expressed by bladder tumor cells and turns on apaziquone to form cytotoxic alkylating cells.
Spectrum is actively enrolling another randomized, placebo-controlled Phase 3 study under a SPA agreement. This study has been designed to expand on findings from the previous Qapzola Phase 3 studies.
The Committee's recommendation is not binding on the FDA's final decision. The Prescription Drug User Fee Act (PDUFA) date for the Qapzola NDA is set for December 11, 2016.
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