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FDA accepts NDA with priority review for RSR13.
2004 MAR 4 - (NewsRx.com & NewsRx.net) -- Allos Therapeutics, Inc., (ALTH) announced that the Division of Oncology Drug Products at the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) seeking approval to market RSR13 (efaproxiral) as an adjunct to whole brain radiation therapy for the treatment of brain metastases in patients with breast cancer.
The FDA also designated the NDA for "priority" review, meaning the FDA will take action on the NDA filing within 6 months from the submission date, or by June 2004. The company completed the rolling submission of its NDA in December 2003 under the FDA's Fast Track designation.
"We are very pleased that the FDA has accepted our NDA for RSR13 for review with a 'priority' designation," said Michael E. Hart, president and CEO of Allos Therapeutics, Inc., "We are one step closer to delivering a potential new treatment for patients suffering from brain metastases from breast cancer."
The NDA filing was based on a 538-patient pivotal phase III study in which 115 patients with brain metastases from breast cancer showed that RSR13 plus whole brain radiation therapy (WBRT) increased median survival by 89%, as compared to WBRT alone (8.67 months versus 4.57 months).
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Source: HighBeam Research, FDA accepts NDA with priority review for RSR13.