Spectrum Pharmaceuticals Bags Fast Track Status For Apaziquone

Spectrum Pharmaceuticals and Allergan have announced that the FDA has granted Fast Track Designation (FTD) for the investigation of apaziquone (EOquin. It is developed for the treatment of non-muscle invasive bladder cancer.

Rajesh Shrotriya, chairman, president and CEO of Spectrum Pharmaceuticals, said: We are pleased that the FDA has accepted apaziquone under its Fast Track program.

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, he added.