Roche Holding AG's Avastin Brain Cancer Drug Gets Japanese Approval-DJ

Monday, 17 Jun 2013 01:20am EDT 

Dow Jones reported that Roche Holding AG said Japan's Ministry of Health approved its Avastin drug for treatment of the aggressive form of brain cancer. The Japanese Ministry of Health, Labour and Welfare has approved Avastin (bevacizumab) for the treatment of malignant glioma, including newly diagnosed glioblastoma (GBM) in combination with radiotherapy and temozolomide chemotherapy, and as monotherapy for treatment of recurrent GBM and certain other types of high grade glioma following prior therapy. Current treatment options for malignant glioma are limited, and Avastin represents the first new medicine approved worldwide for newly diagnosed glioblastoma, the most common and aggressive form of primary brain cancer, in the last eight years. The approval was based on data from three clinical studies in GBM: The phase II BRAIN study; Japanese phase II study (JO22506); The pivotal phase III AVAglio study, which demonstrated that when Avastin was added to standard treatment, patients lived significantly longer without their disease getting worse. 

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