Bevacizumab recommended for accelerated approval in relapsed glioblastoma

Glioblastoma would be the fourth indication for the drug.

On Tuesday, the FDA Oncologic Drugs Advisory Committee voted unanimously to recommend bevacizumab for accelerated approval to treat people with relapsed glioblastoma.

The accelerated approval designation allows earlier approval of drugs that treat serious disease or that fill an unmet medical need based on a surrogate endpoint. Confirmatory studies are then done to show that the drug actually provides clinical benefit. The FDA is expected to make a decision on the approval for this indication by May 2009.

This recommendation is based on data from two phase-2 studies; although data were positive and independently reviewed, both trials were noncomparative.

The application by Genentech was based on data from the AVF3708g study, an open-label, multicenter study, which included 167 patients. Researchers randomly assigned patients with glioblastoma previously treated with temozolomide (Temodar, Schering) and radiation to either bevacizumab (Avastin, Genentech) alone (n=85) or in combination with irinotecan (n=82).

The committee recommended accelerated approval based on data from the single-agent arm of this study.

According to data submitted to the FDA, 28.2% of patients assigned to bevacizumab had an objective response (95% CI, 19.0-38.4); six-month PFS was 42.6% (95% CI, 31.3-53.9). The median PFS was 4.2 months.

The most common grade-3 or higher adverse effect was high blood pressure and seizures. Two deaths associated with adverse events occurred in patients treated with bevacizumab alone.

Bevacizumab is already approved to treat colorectal, lung and breast cancer. – by Leah Lawrence

There are very limited options for patients with recurrent malignant gliomas. Avastin, with or without the concomitant use of CPT11, also called irinotecan, has shown benefit for patients at the time of tumor recurrence and is a welcome addition to the treatment options for patients with malignant gliomas. A major issue in the future that has to be determined is whether the addition of Avastin will improve overall survival in newly diagnosed patients with this disease because to date the use of Avastin in patients with recurrent disease has resulted in some impressive tumor responses but not cure of the illness.
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– Roger Packer, MD

HemOnc Today Editorial Board member