SEP 14 ODAC

The US FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting for Wednesday, September 14, 2016 to discuss new drug application (NDA 208714) for apaziquone for intravesical instillation, application submitted by Spectrum Pharmaceuticals, Inc. (Spectrum). The proposed indication is for immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer.

See the SAC Tracker report