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news.Genentech, a biotechnology company, has reported that the FDA Oncologic Drugs Advisory Committee has unanimously voted that the response seen with Avastin in people with previously treated glioblastoma is of sufficient magnitude to be reasonably likely to predict clinical benefit.
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The FDA is expected to make a decision whether to grant accelerated approval of Avastin for use in this most aggressive form of brain cancer by May 5, 2009.
An accelerated approval of Avastin for previously treated glioblastoma would provide doctors with safety and efficacy information and give people with this rapidly progressing brain cancer a new option. The application is based on positive, independently reviewed data from the non-comparative Phase II Brain study of 167 patients.
David Schenkein, senior vice president of clinical hematology and oncology at Genentech, said: “We look forward to working with the FDA to potentially provide people with this devastating disease the first new treatment in more than a decade. A global Phase III trial evaluating Avastin in people with newly diagnosed glioblastoma will be initiated later in 2009.”