Roche’s Avastin approved to treat aggressive brain cancer in Japan

The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Roche's Avastin for the treatment of rare disease, malignant glioma, in Japan. Avastin (bevacizumab) has also been approved for the treatment of newly diagnosed glioblastoma (GBM), which is the most common and aggressive form of primary brain cancer. Roche's drug is the first new medicine approved worldwide for GBM in the last eight years.

Avastin has been approved for treatment of 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.

"This approval of Avastin is important news for people in Japan who have been diagnosed with glioma and glioblastoma because aggressive brain cancer can significantly reduce a person's quality of life and the ability to perform everyday activities. 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."

Hal Barron MD, Roche's Chief Medical Officer and Head of Global Product Development.

The Japanese approval was based on data from two phase 2 clinical trials in GBM and a pivotal phase 3 clinical trial called AVAglio. AVAglio demonstrated that when Avastin was added to standard treatment, patients lived significantly longer without their disease getting worse.

Roche has filed applications for first-line treatment with health authorities in the EU and Switzerland.