US FDA approves Genentech’s Avastin for glioblastoma

The US Food and Drug Administration (FDA) has provided full approval for Genentech’s Avastin (bevacizumab) to treat adults with glioblastoma that progressed after previous therapy.

Avastin is a biologic antibody formulated to target the vascular endothelial growth factor (VEGF) protein.

Under the FDA’s accelerated approval programme, the drug previously obtained provisional approval for the same setting.

The latest approval, which is based on the results from the EORTC 26101 trial, allows a total of nine different uses of Avastin for six types of cancer in the country.

Genentech chief medical officer and Global Product Development head Sandra Horning said: "Glioblastoma is the most common and aggressive form of brain cancer and can be very difficult to treat.

"Glioblastoma is the most common and aggressive form of brain cancer and can be very difficult to treat."

"Delaying disease progression and reducing the need for corticosteroids over the course of treatment are considered important goals for those impacted by this devastating disease where patients have limited treatment options."

The multi-centre, randomised, open-label Phase III EORTC 26101 trial evaluated Avastin in combination with lomustine chemotherapy for the treatment of 432 subjects with previously treated glioblastoma.

While the trial’s primary endpoint was overall survival (OS), it assessed overall response rate (ORR) and progression-free survival (PFS) as key secondary endpoints.

Results revealed no significant improvement in OS but demonstrated increased time to disease progression or death with Avastin, when compared to chemotherapy alone.

During treatment with Avastin, patients on corticosteroids at baseline were able to completely stop their usage.

The adverse events in the Phase III trial were found to be consistent with those observed in previous trials conducted for various tumour types for approved indications.