FDAnews

ALLOS' DATA MONITORING COMMITTEE RECOMMENDS CONTINUATION OF ENRICH TRIAL

Therapeutics has reported that an independent data monitoring committee has completed an interim analysis of data from the company's Phase III ENRICH trial with efaproxyn and has recommended that the trial continue per the protocol.

ENRICH is a randomized, open-label, multicenter trial designed to compare the effect of whole brain radiation therapy with supplemental oxygen with or without efaproxyn in women with brain metastases originating from breast cancer. The trial is expected to enroll 360 patients at up to 125 sites worldwide. The primary endpoint of the trial would be survival.