13.08.2012 - Phase III results of Roche's unit Genentech Inc. show that a combination therapy including Avastin can significantly extend progression-free survival of patients with glioblastoma.
The AVAglio study investigating Avastin (bevacizumab) plus radiation and temozolomide chemotherapy (Merck's Temodar) in newly diagnosed brain tumour patients has met its co-primary endpoint of a significant improvement in progression-free survival compared with radiation and temozolomide chemotherapy alone. No new safety findings were observed in, and adverse events were consistent with those seen in previous trials of Avastin across its approved tumour types.
Data for the co-primary endpoint of overall survival are expected in 2013. The double-blind, international trial enrolled 921 patients. Basel-headquartered Roche and Genentech plan to discuss the results with EMA, FDA and other global regulatory authorities.
Avastin is currently approved in the US for adults with glioblastoma who have progressive disease following prior therapy and is only licensed for use as a single therapy and not in combination with other treatments. The product is not approved for glioblastoma in Europe.
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