ODAC Split On Avastin Use In First-Line Metastatic Breast Cancer
FDA's Oncologic Drugs Advisory Committee creates a second obstacle to the approval of Genentech's Avastin in metastatic breast cancer by deciding that existing data do not establish a positive risk-benefit profile for a first-line indication. Genentech's primary obstacle is relying on a surrogate endpoint for full approval, in trying to use progression-free survival as a direct measure of clinical benefit
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FDA “Regulatory Flexibility” On Accelerated Approval Must Result In Some Withdrawals
If all drugs cleared for accelerated approval succeed in their confirmatory studies, then FDA is being overly conservative in its use of the expedited approval pathway, FDA Office of Hematology and Oncology Products Director Richard Pazdur says at the AACR annual meeting.
Genentech Bid To Gain Full Approval For Avastin On Amassed PFS Data Gets July ODAC Hearing
Roche division also seeks approval for bevacizumab in new combinations based on AVADO and RIBBON-1 trial results, but the question remains whether the progression-free survival endpoint used in all the trials is sufficient for full approval.
AVADO Presented At ASCO; But After The Fanfare, What Does It Signify?
CHICAGO - With the positive results of Roche's AVADO study of Avastin in first-line metastatic breast cancer, Roche and Genentech have the value of having a placebo-controlled, double-blind confirmation of bevacizumab's use in that setting. But what the presentation of AVADO at the American Society of Clinical Oncology annual meeting really did was revive debate over the breast cancer approval and raise questions about proper use in that setting