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Complete response letter for Spectrum's Qapzola

November 18, 2016 10:49 PM UTC

Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said it received a complete response letter from FDA for its non-muscle invasive bladder cancer (NMIBC) candidate Qapzola apaziquone. Based on discussions with the agency, Spectrum is considering a new smaller study of Qapzola that would replace its ongoing Phase III trial. The company has halted enrollment in that trial.

In September, FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-0 that Qapzola had not shown substantial efficacy over placebo in treating NMIBC following transurethral resection of bladder tumors (TURBT). The candidate is an analog of mitomycin C that is reduced by intracellular reductases into active DNA-damaging moieties...

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Spectrum Pharmaceuticals Inc.