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GEN News Highlights : Jun 17, 2013

Roche’s Avastin Earns First Approval for Aggressive Brain Cancer in Japan

Roche today announced its Avastin has been approved in Japan for the treatment of aggressive brain cancers. More specifically, Japan gave Avastin an OK 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, as well as certain other types of high-grade glioma following prior therapy.

This approval—a first for Avastin—follows on the heels of Roche’s recent presentation of some disappointing data for its Phase III AVAglio trial, evaluating the drug plus radiotherapy and temozolomide chemotherapy for the treatment of newly diagnosed glioblastoma, at the annual American Society of Clinical Oncology meeting earlier this month. In a presentation at ASCO, Roche said the Avastin-radiotherapy-temozolomide chemo combination did not significantly improve overall survival.

“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,” Roche said today.

The company said its Japan approval was based on results from three clinical studies—the Phase II BRAIN study, JO22506 (a Japanese Phase II study), and AVAglio.

“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,” Hal Barron, M.D., Roche CMO and head of Global Product Development, said in a statement.

“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,” Dr. Barron added.

Japan designated Avastin an orphan drug for malignant glioma this May. Roche Group member Chugai Pharmaceutical markets Avastin in the country.