Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted full approval for Avastin® (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as recurrent disease). Avastin was previously granted provisional approval in this setting under the FDA's accelerated approval program.
“Glioblastoma is the most common and aggressive form of brain cancer and can be very difficult to treat,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “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.”
This conversion to full approval was based on the totality of evidence of Avastin in glioblastoma, including data from the Phase III EORTC 26101 study. Avastin is now approved in the United States for nine distinct uses across six different types of cancer.
About the EORTC 26101 Study
EORTC 26101 is an independent Phase III, multicenter, randomized, open-label trial, conducted by the European Organization for Research and Treatment of Cancer (EORTC), that evaluated the addition of Avastin to lomustine chemotherapy in 432 patients with previously treated glioblastoma. The primary endpoint of the study was overall survival (OS), and progression-free survival (PFS) as assessed by investigator and overall response rate (ORR) were key secondary endpoints. Results showed the following:
- There was no significant increase in OS with Avastin-based treatment (HR=0.91, p=0.4578).
- As the primary endpoint was not met, all secondary endpoints should be considered descriptive only.
- Avastin-based treatment increased the time to disease progression or death compared to chemotherapy alone (median PFS: 4.2 months vs. 1.5 months, HR=0.52, 95% CI: 0.41-0.64).
- Among people taking corticosteroids at baseline (50 percent), more people were able to completely stop intake of corticosteroids while on treatment in the Avastin arm compared to the control arm (23 percent vs. 12 percent).
- In the Avastin with lomustine arm, 22 percent of people discontinued treatment due to adverse reactions compared with 10 percent of people in the lomustine arm.
- Adverse events were consistent with those seen in previous trials of Avastin across tumor types for approved indications.
Glioma (cancer of the glial cells) is the most common type of malignant primary brain tumor (a tumor that originates in the brain), and represents nearly one-fourth of all primary brain tumors and three-fourths of all malignant tumors. Glioblastoma (or glioblastoma multiforme) is the most common and the most aggressive type of glioma, accounting for more than half of all gliomas. It is estimated that more than 12,300 people will be diagnosed with glioblastoma in the United States in 2017.
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Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize).