According to Eisai, Gliadel wafer is the only FDA-approved chemotherapeutic implant for use during surgical procedures for malignant glioma. Gliadel wafer has been approved in 18 countries worldwide, primarily in North America, Europe, and Southeast Asia.
Early approval of Gliadel wafer has been requested in Japan and it was taken as a subject in 2008 by the Investigational Committee for Usage of Unapproved Drugs, a body established by the Ministry of Health Labour and Welfare.
Eisai expects that the development of Gliadel wafer by Nobelpharma will bring a new treatment option to patients with malignant glioma in Japan as early as possible.