The Japanese Ministry of Health, Labour and Welfare (MHLW) has cleared Roche's Avastin (bevacizumab) as a combination therapy and monotherapy to treat the aggressive form of brain cancer glioblastoma.
The first new medicine that is globally approved for newly diagnosed glioblastoma is cleared for use in combination with radiotherapy and temozolomide chemotherapy, and as monotherapy.
Avastin is designated as an orphan drug for malignant glioma in Japan and will be marketed by a member of the Roche Group, Chugai Pharmaceutical.
Roche chief medical officer and global product development head Hal Barron said, "People with newly diagnosed glioblastoma who received Avastin plus radiotherapy and temozolomide chemotherapy in the pivotal study experienced a significantly longer period of time without their cancer worsening."
Positive data from three clinical studies in GBM, the phase II BRAIN study, a Japanese phase II study (JO22506) and the pivotal phase III AVAglio study, supported the approval.
