SEP 14 ODAC

On Wednesday, September 14, 2016, the Oncologic Drugs Advisory Committee (ODAC) did not support, by a vote of 0-Yes to 14-No, with no abstentions, the safety and efficacy of Qapzola (apaziquone) for intravesical instillation, by Spectrum Pharmaceuticals, Inc. (Spectrum). The proposed indication is immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer (NMIBC).

See the SAC Tracker report