Spectrum Pharmaceuticals and Allergan, Inc announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for the investigation of apaziquone (EOquin) 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 per cent of all newly diagnosed patients with bladder cancer have non-muscle invasive bladder cancer. 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 programme," said Rajesh C Shrotriya, chairman, president, and chief executive officer of Spectrum Pharmaceuticals. "In a marker lesion study, where patients had previously failed multiple therapies, apaziquone produced a 67 per cent 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. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process.
The frequency of communication facilitates the sponsor's ability to expeditiously address questions and issues. A drug that receives Fast Track designation is eligible for a Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
Spectrum Pharma is a commercial-stage biotechnology company with a focus in oncology.
Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully.