Gliadel Wafer: Phase III data; Marketed to treat recurrent glioblastoma multiforme

In a placebo-controlled, international Phase III trial of 240 glioma patients who received Gliadel implants at the time of initial surgery along with radiation therapy, median survival was 13.9 months for Gliadel patients compared to 11.6 months for patients given placebo (p<0.03). At 1 year, 59 percent of Gliadel-treated patients were alive compared to 48 percent of the placebo group (p<0.01). The frequency of re-operation for tumor progression was 27 percent in both groups, however the median time to tumor progression occurred 2 months earlier in the placebo group. GLFD said that after accounting for the effect of re-operation, Gliadel prolonged survival by 4 months compared to placebo (p<0.004). Gliadel also significantly improved neurological symptoms compared to placebo, and was well tolerated.

Data were presented at the Society for Neuro-Oncology meeting in Chicago. GLFD said it expects to submit in the first half of 2001 an sNDA to the FDA for approval of Gliadel as a first-line therapy for newly diagnosed malignant glioma at the time of initial surgery. ...