The approval follows a priority review of the company’s new drug application submission, which was granted in September 2005 to satisfy an unmet medical need in Japanese patients. Temodal (temozolomide), marketed as Temodar in the US, is approved in 77 countries.
In Japan, Temodal is indicated for both treatment-naive newly-diagnosed patients (in combination with radiotherapy), and previously treated patients with malignant gliomas.
The Japanese Ministry of Health, Labor and Welfare (MHLW) approval is based on efficacy and safety data from six studies including a study of 32 Japanese patients with recurrent anaplastic astrocytoma, and a phase III study conducted by the European Organisation for Research and Treatment of Cancer (EORTC) and the National Cancer Institute of Canada (NCIC).
The phase III study involved 573 patients with newly diagnosed glioblastoma multiforme and demonstrated longer survival in the patients who received Temodal and radiation compared with those who received only radiation.
Temodal will become available upon determination of pricing by the MHLW. It will be available in 20mg and 100mg capsule strengths.