IRVINE, Calif. Spectrum Pharmaceuticals and Allergan, Inc. announced that the Food and Drug Administration has granted fast track designation for the investigation of apaziquone for the treatment of non-muscle invasive bladder cancer, a form of bladder cancer localized in the surface layers of the bladder that has not spread to the deeper muscle layer.
Approximately 70% of all newly diagnosed patients with bladder cancer have non-muscle invasive bladder cancer, the companies said. More than one million patients in the United States and Europe are estimated to be affected by the disease.
“We are pleased that the FDA has accepted apaziquone under its fast track program,” said Rajesh C. Shrotriya, chairman, president and CEO of Spectrum Pharmaceuticals. “In a marker lesion study, where patients had previously failed multiple therapies, apaziquone produced a 67% complete response and was well-tolerated. We look forward to continuing with Phase 3 studies evaluating the efficacy and safety of apaziquone, while working with the FDA to expedite the drug’s development, review and approval process so we can help address the substantial unmet needs of patients suffering from non-muscle invasive bladder cancer.”
Fast track designation is designed to facilitate drug development and expedite the review of drugs intended to treat serious conditions and demonstrate the potential to address unmet medical needs.