After Avastin, Seeking Clarity On Progression-Free Survival Endpoints
Executive Summary
Rather than damaging the use of progression-free survival as an endpoint in oncology clinical trials, as some have feared, the battle over Avastin’s (bevacizumab) metastatic breast cancer claim could give sponsors some clarity as to how the US FDA expects the magnitude of progression-free survival benefit to be defined.
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Avastin Debate Could Provide Clarity On Use Of Progression-Free Survival Endpoints
Rather than damaging the use of progression-free survival as an endpoint in oncology clinical trials, as some have feared, the battle over Avastin’s (bevacizumab) metastatic breast cancer claim could give sponsors some clarity as to how FDA expects the magnitude of PFS benefit to be defined.
Avastin’s Breast Cancer Claim: Will FDA’s Hamburg Take A Middle Road?
FDA Commissioner Margaret Hamburg faces a decision on the future of Avastin’s (bevacizumab) first-line metastatic breast cancer claim that may not be so cut and dried as the Oncologic Drugs Advisory Committee’s unanimous vote favoring the indication’s withdrawal suggests.
Accelerated Approval Remains “Viable Pathway,” FDA’s Woodcock Says
FDA’s accelerated approval program is alive and well now, and will remain a viable pathway in the future, despite concerns within the industry and investor communities that recent oncology regulatory actions are hastening the program’s demise.