FDA GIVES NEOPHARM OK FOR DATA ANALYSIS

The FDA has approved an amendment to NeoPharm's clinical trial to test a new brain tumor treatment.

The approval allows the company to include an interim analysis of data to see how the treatment cintredekin besudotox compares with patients receiving the Gliadel wafer, an implanted wafer made by Guilford Pharmaceuticals that releases chemotherapy drugs locally. The agency had recommended that the company propose the analysis.

The interim analysis will be triggered when 160 deaths have occurred in the trial, at which point, researchers will compare the survival of patients taking cintredekin besudotox versus those with the Gliadel wafer. A final analysis will occur when 215 deaths have occurred.