On September 2, 2015 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has received notification from Japan’s Ministry of Health, Labour and Welfare (MHLW) to the effect that the "all-case surveillance" survey condition required for approval of Gliadel 7.7mg Implant (carmustine, "Gliadel") has been lifted (Press release, Eisai, SEP 2, 2015, View Source [SID:1234507378]). Schedule your 30 min Free 1stOncology Demo! In September 2012, the MHLW approved Gliadel indicated for malignant glioma with the following condition for approval: "Because of the very limited number of subjects treated in the Japanese clinical trials, the applicant is required to conduct all-case drug use-results survey until data from a certain number of patients are accumulated after market launch, in order to identify the background information of patients treated with the product and collect safety and efficacy data on the product in the early post-marketing period, and thereby take necessary measures to ensure proper use of the product."
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The MHLW lifted this condition for approval after evaluating safety and efficacy data submitted by Eisai from patients with malignant glioma (558 cases for safety analysis, 536 cases for efficacy analysis). According to the results of the evaluation, the MHLW determined that the conditions for approval have been met.
Gliadel is the only sustained-release formulation approved for intracranial implantation in Japan. Each wafer contains the nitrosourea alkylating agent carmustine distributed in a biodegradable polymer matrix. Implanting the agent into the brain following surgical removal of malignant glioma allows for direct delivery of chemotherapy to the tumor site, allowing the agent to be used prior to initiating radiation, chemotherapy and other standard therapies. Gliadel is manufactured and distributed by Eisai, and the product is co-promoted by Eisai and Nobelpharma Co., Ltd.
Eisai will continue to promote and provide information on the proper use of Gliadel while making further contributions to improve the quality of life of patients.