Allos Efaproxyn "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Allos' radiation sensitizer Efaproxyn (efaproxiral, RSR-13) is "approvable" May 27 for treatment of brain metastases originating from breast cancer. Approval is contingent upon successful completion of the Phase III ENRICH study. "If the study shows effectiveness in this population (increased survival) using the pre-specified analysis, and the study is otherwise satisfactory, we believe it would, together with the subset result in RT-009, support approval," FDA's letter states. Allos limited the RSR-13 filing to breast cancer after the RT-009 trial showed significance in a subset of patients with breast cancer, but not in the overall population (1Pharmaceutical Approvals Monthly Dec. 1, 2003, p. 6). Allos announced European submission of efaproxiral June 4 for the same indication, under the centralized procedure...