Wednesday March 20, 9:15 am Eastern Time
Press Release
SOURCE: Guilford Pharmaceuticals, Inc.
Guilford Pharmaceuticals Receives FDA Review Letter for GLIADEL(R) Wafer
BALTIMORE, March 20 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc., (Nasdaq: GLFD - news) announced today that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) concerning its supplemental New Drug Application for GLIADEL® Wafer (polifeprosan 20 with carmustine implant) for the treatment of patients with newly diagnosed malignant glioma. In 1996, GLIADEL® Wafer received FDA approval for use as an adjunct to surgery in patients with recurrent glioblastoma multiforme.
The supplemental New Drug Application was based on data from a Phase III, randomized, double-blind, placebo-controlled study conducted at 38 centers in 14 countries, involving 240 patients undergoing initial surgery for malignant glioma. Patients in the study were randomly assigned to receive either GLIADEL® Wafer or placebo wafers. The primary endpoint in the study was overall survival in all patients enrolled in the trial.
Guilford's analysis of survival indicated that, relative to the placebo group, the GLIADEL® Wafer group had a hazard ratio of 0.71, meaning a 29% reduction in the risk of dying during the trial. Guilford determined that the p value for this treatment effect was p=0.03 using the log rank test, stratified by the country in which treatment was administered.
The FDA's analysis of survival in the trial indicated that, relative to the placebo group, the GLIADEL® Wafer group had a hazard ratio of 0.77, meaning a 23% reduction in the risk of dying during the trial. In a letter to the Company, the FDA stated: ``Trial T-301 ... was a single, multi-center, randomized, placebo-controlled trial whose primary endpoint failed to reach statistical significance by the protocol-specified log rank test. The analysis of survival, which was the primary endpoint, showed no significant difference between study arms (log rank p=0.08).'' While the FDA made other points to support its conclusion, its letter did not raise any issues concerning the safety of the product when used in the initial surgery setting.
GLIADEL® Wafer is currently marketed in the United States and 23 other countries for the treatment of recurrent glioblastoma multiforme, and in Canada for the treatment of recurrent and newly diagnosed malignant glioma. |
