FDA grants bevacizumab accelerated approval for relapsed glioblastoma

Yesterday, the FDA granted bevacizumab accelerated approval for the treatment of relapsed glioblastoma.

On March 31, the FDA Oncologic Drugs Advisory Committee voted unanimously to recommend the drug for accelerated approval. This designation allows provisional approval of drugs that treat serious disease or that fill an unmet medical need based on a surrogate endpoint.

The approval was based on data from two phase-2 studies that showed an improvement in objective response rate. There are currently no data available from randomized, controlled trials showing an improvement in disease-related symptoms or increased survival from the drug.

Data from both studies were positive and independently reviewed, but neither trial was comparative.

The application 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, 26% of patients assigned to bevacizumab had an objective response (95% CI, 17%-36.1%); six-month PFS was 42.6% (95% CI, 31.3-53.9). The median PFS was 4.2 months (95% CI, 3.0-5.7).

The second study was a single-arm study of the drug. Fifty-six patients were treated with bevacizumab alone. Twenty percent of patients responded to the drug (95% CI, 10.9%-31.3%). Median duration of response was 3.9 months (95% CI, 2.4-17.4).

The most common grade-3 or higher adverse effects were high blood pressure and seizures. Two deaths possibly 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

This is a great advance for our patients with glioblastoma because bevacizumab is really the first drug that has shown a clear cut improvement in quality of life for these patients. I am very encouraged that it will now be available to patients across the country who have recurrent glioblastoma. It is also well timed because there is a lot of experience with this drug in other malignancies and unfortunately, we do not have other drugs that have been effective for patients who have recurrent glioblastoma. The FDA has done the right thing giving this drug accelerated approval. Finally, although this is a very exciting development and it gives us all encouragement in treating our patients, I would still urge physicians to offer clinical trials to patients with this disease because we still have a lot of work to do.

– David M. Peerebom, MD

Associate Professor at the Cleveland Clinic Lerner College of Medicine