Schering-Plough Temodal

Executive Summary

Average wholesale price of temozolomide following FDA approval could be $300 per day for a 200 mg/m2 dose. A post-hoc economic analysis of a Phase III trial in metastatic melanoma presented at the American Society of Clinical Oncology used the AWP figure to determine that Temodal would have a mean cost of $6,902 per patient compared to $3,697 per patient for treatment with DTIC. FDA's Oncologic Drugs Advisory Committee recommended against approval of the drug for metastatic melanoma and glioblastoma multiforme in January. Temodal became "approvable" for the treatment of anaplastic astrocytoma Feb. 2 ("The Pink Sheet" March 15, p.15)