LITTLE FALLS, N.J., May 6 -- The FDA gave bevacizumab (Avastin) fast-track approval for the treatment of glioblastoma patients who have been unresponsive to prior therapy, according to drugmaker Genentech.
The accelerated approval followed two pilot studies showing that it improved response rates in patients with glioblastoma.
One study, AVF3708g, included 167 patients with glioblastoma that had progressed after initial treatment with temozolomide and radiation. Patients were randomized to either bevacizumab alone or bevacizumab plus irinotecan.
Tumor responses were observed in 26% of the 85 patients treated with bevacizumab alone. Median duration of response was 4.2 months.
In a separate, single-arm study, NCI 06-C-0064E, about 20% of the 56 patients treated with bevacizumab had response rates, and median duration of response was 3.9 months.
Common adverse events included infection, fatigue, headache, high blood pressure, diarrhea, and nose bleeds.
Others included bleeding, hemorrhage, wound-healing complications, gastrointestinal perforation, and posterior leukoencephalopathy syndrome.
Gastrointestinal perforation occurred in 0.3% to 2.4% of patients. Bleeding occurred up to five times more frequently in patients taking bevacizumab, according to Genentech.
The company warned that the drug should not be initiated for at least 28 days following surgery, and until the surgical wound is fully healed.
Two deaths may have been associated with adverse events, including one retroperitoneal hemorrhage and one neutropenic infection.