NDA completed for treatment of breast cancer with brain metastases.

2004 JAN 1 - (NewsRx.com & NewsRx.net) -- Allos Therapeutics, Inc., (ALTH) announced that it has submitted to the U.S. Food and Drug Administration (FDA) the last component of its new drug application (NDA) for approval to market RSR13 (efaproxiral) as an adjunct to whole brain radiation therapy for the treatment of brain metastases from breast cancer.

The company submitted the first component of its NDA for RSR13 in August 2003 under the FDA's rolling submission process and has now completed this process with the submission of clinical efficacy and safety data. With the entire NDA submission now completed, the FDA has 60 days to notify the company of whether or not it will accept the NDA for filing and respond to the company's request for priority review of the application.

The electronic submission was produced in an internationally agreed upon format (eCTD) that facilitates regulatory review in the United States, Europe and Japan. The company plans to submit a marketing authorization application (MAA) in Europe for this indication in the first quarter of 2004.

RSR13 is the first of a new class of pharmaceutical agents being developed as a radiation sensitizer to be used as an adjunct to radiation therapy. A synthetic small molecule, RSR13 decreases the hemoglobin-oxygen binding affinity, which facilitates the release of oxygen from hemoglobin. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy in the treatment of cancer. By increasing the oxygenation of tumor tissues at the time of treatment, RSR13 has the potential to sensitize hypoxic (oxygen deprived) tissues and enhance the efficacy of standard radiation therapy. Unlike chemotherapeutics or other radiosensitizers, RSR13 does not have to cross the blood brain barrier or enter the tumor to be effective.