S-P's Temodal approved for glioma by MHLW
New Jersey, USA-based Schering-Plough says that the Japanese Ministry of Health, Labor and Welfare has approved Temodal (temozolomide capsules) for use in the treatment of glioma. The MHLW's decision follows its priority review of the product, which it began in September last year.
The Japanese indication includes the product's use by both treatment-naive newly-diagnosed patients, in combination with radiotherapy, as well as treatment-experienced individuals. The original New Drug Application was based on data from a Phase III trial, published last year in the March 10 issue of the New England Journal of Medicine, which showed that the product, in combination with radiotherapy, extended survival time in treated patients.
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