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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