FDA Designates Fast Track Status For Apaziquone (EOquin(R)) For Bladder Cancer

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Urology / Nephrology
Article Date: 22 Jul 2009 - 6:00 PDT

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Spectrum Pharmaceuticals (NasdaqGM: SPPI) and Allergan, Inc. (NYSE:AGN) today announced that the U.S. 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% of all newly diagnosed patients with bladder cancer have non-muscle invasive bladder cancer.1 More than one million patients in the United States and Europe are estimated to be affected by the disease.2

"We are pleased that the FDA has accepted apaziquone under its Fast Track program," said Rajesh C. Shrotriya, MD, 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% 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.

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology. The Company's strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for its approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in its areas of focus; and, leveraging the expertise of partners around the world to assist it in the execution of its strategy. For more information, please visit the Company's website at http://www.spectrumpharm.com.

Source
Allergan, Inc.

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