The US Food and Drug Administration (FDA) has granted fast-track designation to investigate apaziquone, a new bladder cancer drug from Spectrum Pharmaceuticals and Allergen.
Apaziquone (EOquin) is being tested for the treatment of non-muscle invasive bladder cancer, which is localised in the surface layers of the bladder and not in the deeper muscle layer.
Non-invasive bladder cancer is the most common form of bladder cancer and affects more than a million people in the US.
The new drug was afforded fast-track status under a new initiative to speed up drug development to treat serious conditions.
Spectrum Pharmaceuticals MD, chairman, president and chief executive officer Rajesh C Shrotriya said that 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,” Shrotriya said.
Once fast-track status is granted by the FDA the product will be eligible for a Rolling Review, under which a drug company can submit completed sections of its New Drug Application for FDA review, rather than waiting for every section to be completed.
During fast tracking, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process.