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Efaproxiral NDA Gains Priority Review by FDA, Adjunct to Whole Brain Radiation Therapy
WESTMINSTER, Colo., Feb. 3 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. announced today 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 six 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."
About the RSR13 NDA Filing
The NDA filing was based on a 538-patient pivotal Phase 3 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 percent, as compared to WBRT alone (8.67 months versus 4.57 months). Patients with brain metastases from breast cancer who received RSR13 plus WBRT experienced a 51 percent reduction in risk of death as compared to patients who received WBRT alone. In addition, patients with brain metastases from breast cancer who were treated with RSR13 plus WBRT also achieved a statistically significant increase in response rate in the brain as compared to the control group. The addition of RSR13 to WBRT was safe and well tolerated.
RSR13 is the first synthetic small molecule designed to "sensitize" hypoxic (oxygen-deprived) areas of tumors prior to radiation therapy by facilitating the release of oxygen from hemoglobin, the oxygen-carrying protein contained within red blood cells, and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy in the treatment of cancer. By increasing tumor oxygenation at the time of treatment, RSR13 has the potential to enhance the efficacy of standard radiation therapy. Unlike chemotherapeutics or other radiation sensitizers, RSR13 does not have to cross the blood brain barrier or enter the tumor to be effective.
Source: Allos Therapeutics, Inc.