Avastin Down, But Not Out Yet In Metastatic Breast Cancer Indication
Executive Summary
FDA's decision to withdraw approval of Roche/Genentech's Avastin for first-line metastatic breast cancer is proving to be an unpopular action, though the ramifications are not yet clear.
You may also be interested in...
Product Withdrawal Can Be As Hard As Approval: Luveris' 4-Year Journey Ends
EMD Serono had not marketed the infertility treatment in US since 2012, when it first asked FDA to withdraw application; company was unable to complete confirmatory trial required under accelerated approval.
Perjeta, Avastin Breast Cancer Approvals Are A Study In Contrasts
Pertuzumab’s approval came almost a year after FDA and Genentech battled over the future of bevacizumab’s breast cancer claim at an unprecedented public hearing. While both oncologic agents were approved on the basis of a median progression-free survival benefit exceeding five months, the regulatory similarities end there.
Women's Right To Choose Avastin Debated During House PDUFA Hearing
Discussion of the status of Avastin's indication for metastatic breast cancer at a July 7 House hearing can be seen as a surrogate for several debates that could unfold during the user fee reauthorization process – including FDA approval standards, conflict-of-interest screening for advisory committees and pricing.