Allos Therapeutics, Inc., a biopharmaceutical company, announced that the Division of Oncology Drug Products at the US 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 Hart, president and CEO of Allos. "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 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 per cent, 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 per cent 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.