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Allos Therapeutics, Inc.

NDA for radiation therapy sensitizer to be reviewed by FDA panel

Published in FDA Law Weekly, April 15th, 2004

Allos Therapeutics, Inc., (ALTH) announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) plans to review the company's investigational radiation sensitizer, RSR13 (efaproxiral), on May 3, 2004.

On February 2, 2004, the FDA accepted for priority review the company's New Drug Application (NDA 21-661) seeking approval to market RSR13 as an adjunct to whole brain radiation therapy for the treatment of patients with brain metastases originating from breast cancer. The FDA has established a target date of June 4, 2004, to take action on the NDA.

"We welcome the additional review and insight the FDA's...

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