FDA advisory committee negative for Qapzola (apaziquone) to treat non-muscle invasive bladder cancer.- Spectrum Pharma.

Spectrum Pharmaceuticals announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted that Qapzola for immediate intravesical instillation post-transurethral resection of bladder tumours (post-TURBT) has not shown substantial evidence of a treatment effect over placebo in patients with non-muscle invasive bladder cancer (NMIBC). The committee recommendation is not binding on the FDA, which makes the final decision on approval. The Prescription Drug User Fee Act (PDUFA) date for the Qapzola NDA is December 11, 2016.