RSR13Treatment for Brain Metastases in patients with Breast Cancer
Allos NDA To Be Reviewed By FDA Advisory Committee
WESTMINSTER, Colo., March 12, 2004 – Allos Therapeutics, Inc. (Nasdaq: ALTH) announced today 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. The company has submitted a New Drug Application (NDA) to the FDA seeking approval to market RSR13 (efaproxiral) as an adjunct to whole brain radiation therapy for the treatment of patients with brain metastases originating from breast cancer. Information regarding the ODAC panel is now available via the FDA Hotline at 1-800-741-8138 and will soon be posted to the Federal Register.
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 outside scientific advisors will provide at the ODAC hearing,” said Michael E. Hart, President and CEO of Allos Therapeutics, Inc. “The recent acceptance for priority review of our NDA exemplifies our ongoing cooperative efforts with the FDA.”
About RSR13 (efaproxiral)
RSR13 (efaproxiral) 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 (efaproxiral) has the potential to enhance the efficacy of standard radiation therapy. Unlike chemotherapeutics or other radiation sensitizers, RSR13 (efaproxiral) does not have to cross the blood brain barrier or enter the tumor to be effective.
About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative drugs for improving cancer treatments. The company’s lead clinical candidate, RSR13 (efaproxiral), is a synthetic small molecule that has the potential to sensitize hypoxic (oxygen deprived) tumor tissues and enhance the efficacy of standard radiation therapy. In addition, Allos is developing PDX, an injectable small molecule chemotherapeutic agent that has a superior potency and toxicity profile relative to methotrexate and other dihydrofolate reductase, or DHFR, inhibitors.
Posted: March 2004
- Allos Therapeutics Announces New Trade Names for Efaproxiral in the U.S. and Europe - June 16, 2004
- Allos Therapeutics Receives FDA Approvable Letter for RSR13 (efaproxiral) - June 2, 2004
- FDA Advisory Committee Does Not Recommend Approval of RSR13 as Adjunctive Therapy for the Treatment of Brain Metastases Originating From Breast Cancer - May 4, 2004
- FDA Accepts Allos New Drug Application with Priority Review for RSR13 in Brain Metastases from Breast Cancer - February 3, 2004