FDA Drug Approval Summary: Bevacizumab (Avastin®) as Treatment of Recurrent Glioblastoma Multiforme
United States Food and Drug Administration · Center for Drug Evaluation and Research
Abstract
Abstract Learning Objectives After completing this course, the reader will be able to: Discuss and compare currently approved drugs for treatment of glioblastoma multiforme (GBM) and explain the advantages of bevacizumab for GBM treatment.Debate the use of response rate as an endpoint for GBM treatment with bevacizumab.Differentiate between accelerated and regular drug approval by the Food and Drug Administration. This article is available for continuing medical education credit at CME.TheOncologist.com. On May 5, 2009, the U.S. Food and Drug Administration granted accelerated approval to bevacizumab injection (Avastin®; Genentech, Inc., South San Francisco, CA) as a single agent for patients with glioblastoma…
Citation impact
- FWCI
- 16.40
- Percentile
- 100%
- References
- 28
Authors
4- MHMartin H. CohenCorresponding
United States Food and Drug Administration, Center for Drug Evaluation and Research
- YLYuan Li Shen
United States Food and Drug Administration, Center for Drug Evaluation and Research
- PKPatricia Keegan
United States Food and Drug Administration, Center for Drug Evaluation and Research
- RPRichard Pazdur
United States Food and Drug Administration, Center for Drug Evaluation and Research
Topics & keywords
- Medicine
- Bevacizumab
- Temozolomide
- Irinotecan
- Clinical endpoint
- Internal medicine
- Clinical trial
- Oncology
- Good health and well-being