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Japan’s MHLW Approves S-P’s Brain Cancer Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Schering-Plough received approval from the Japan Ministry of Health, Labor and Welfare (MHLW) for Temodal capsules for the treatment of malignant glioma.

The approval follows a priority review of the J-NDA submission, which was granted in September of 2005 in order to satisfy an unmet medical need in Japanese patients. Temodal, marketed as Temodar in the U.S., is approved in 77 countries. Temodal will become available once pricing is determined by the Japanese MHLW.

Malignant gliomas are primary brain tumors that develop from glial cells. Approximately 30% of primary brain tumors are gliomas, which affect approximately six to eight people per 100,000 people worldwide. Both glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are types of high-grade gliomas. GBM is the most common and aggressive form of primary brain tumor. Approximately 2,500 patients are diagnosed with malignant glioma in Japan each year.

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