Roche study showed that adding Avastin to radiation and chemotherapy

In the study, Avastin in combination with radiation and temozolomide chemotherapy significantly extended the time people with this aggressive form of primary brain cancer lived without their disease getting worse (PFS), compared to those treated with radiation and temozolomide chemotherapy plus placebo. Data for final overall survival (OS), the other co primary endpoint, are expected in 2013. No new safety findings were observed in the AVAglio study and adverse events were consistent with those seen in previous trials of Avastin across tumour types for approved indications. Full data from the AVAglio study will be submitted for presentation at an upcoming medical meeting.

“This study showed that people with glioblastoma, a particularly devastating and aggressive cancer without many treatment options, lived significantly longer without their disease worsening when Avastin was added to radiation and temozolomide chemotherapy,” said Hal Barron M.D., Chief Medical Officer and Head Global Product Development.

Avastin is currently approved in the United States and over 30 countries worldwide for the treatment of glioblastoma as a single agent and in some countries in combination with irinotecan for adult patients with progressive disease following prior therapy (relapsed setting). The approval in the USA was granted under the Food and Drug Administration’s (FDA) accelerated approval programme.

Roche plans to discuss these phase III results with global regulatory authorities, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

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