Qapzola apaziquone regulatory update

FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-0 that Qapzola apaziquone from Spectrum has not shown substantial efficacy over placebo in treating non-muscle invasive bladder cancer (NMIBC) following transurethral resection of bladder tumors (TURBT). The PDUFA date is Dec. 11. Qapzola is an analog of mitomycin C that is reduced by intracellular reductases into active DNA-damaging moieties. ...