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Spectrum’s Bladder Cancer Drug Fast Tracked

Spectrum Pharmaceuticals received Fast Track designation from the FDA for apaziquone in bladder cancer.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Spectrum Pharmaceuticals received Fast Track designation from the FDA for apaziquone in bladder cancer. Fast Track 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.

“We are pleased that the FDA has accepted apaziquone for bladder cancer under its Fast Track program,” said Rajesh C. Shrotriya, M.D., chairman, president, and chief executive officer of Spectrum. “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 III 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.”

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