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Antiangiogenesis Therapy
Source: Central Nervous System Tumors Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: March 28, 2025 · Captured 2026-09-09.
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Context: Treatment of Recurrent CNS Tumors
In 2009, the U.S. Food and Drug Administration (FDA) granted accelerated approval of bevacizumab monotherapy for patients with progressive glioblastoma. The indication was granted under the FDA’s accelerated approval program that permits the use of certain surrogate end points or an effect on a clinical end point other than survival or irreversible morbidity as bases for approvals of products intended for serious or life-threatening illnesses or conditions.
The approval was based on the demonstration of improved objective response rates observed in two historically controlled, single-arm, or noncomparative phase II trials.[3,4][Level of evidence C3] Based on these data and the FDA approval, bevacizumab monotherapy has become standard therapy for recurrent glioblastoma.
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Evidence (antiangiogenesis therapy):
The FDA independently reviewed an open-label, multicenter, noncomparative phase II study that randomly assigned 167 patients with recurrent glioblastoma multiforme (GBM) to receive bevacizumab alone or bevacizumab in combination with irinotecan.[3] However, only efficacy data from the bevacizumab monotherapy arm (n = 85) were used to support drug approval.
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The FDA independently reviewed an open-label, multicenter, noncomparative phase II study that randomly assigned 167 patients with recurrent glioblastoma multiforme (GBM) to receive bevacizumab alone or bevacizumab in combination with irinotecan.[3] However, only efficacy data from the bevacizumab monotherapy arm (n = 85) were used to support drug approval.
Tumor responses were observed in 26% of patients treated with bevacizumab alone, and the median duration of response in these patients was 4.2 months.
The FDA independently reviewed an open-label, multicenter, noncomparative phase II study that randomly assigned 167 patients with recurrent glioblastoma multiforme (GBM) to receive bevacizumab alone or bevacizumab in combination with irinotecan.[3] However, only efficacy data from the bevacizumab monotherapy arm (n = 85) were used to support drug approval.
Based on this externally controlled trial, the incidence of adverse events associated with bevacizumab did not appear to be significantly increased in GBM patients.
The FDA independently assessed another single-arm, single-institution trial in which 56 patients with recurrent glioblastoma were treated with bevacizumab alone.[4]
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The FDA independently assessed another single-arm, single-institution trial in which 56 patients with recurrent glioblastoma were treated with bevacizumab alone.[4]
Responses were observed in 20% of patients, and the median duration of response was 3.9 months.
No data are available from prospective randomized controlled trials demonstrating improvement in health outcomes, such as disease-related symptoms or increased survival with the use of bevacizumab to treat glioblastoma.
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Preserved source evidence · Not medical advice