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OBR OncologyThe ‘Juggernaut’ of Accelerated Approvals: Is the System Working?

Mikkael A. Sekeres, MD, currently Chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center at the University of Miami, worked on the decision to remove Avastin’s indication for the treatment of HER2-negative metastatic breast cancer in 2008. As a result of the hearing, Dr. Sekeres poses the following question in his most recent book, Drugs and the FDA: Safety, Efficacy, and the Public’s Trust: “Had the FDA made a mistake in initially approving the drug?” Dr. Sekeres discussed with OBR the rise of accelerated approvals, progression-free survival as an endpoint, and the consequences of the Avastin hearing.

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