Avastin Breast Cancer Approval Debate Pits Clinical Benefit Versus Statistics
The Oncology Drugs Advisory Committee's vote against full approval of Roche's Avastin (bevacizumab) for first-line treatment of metastatic breast cancer hinged to a large degree on its feeling that the drug did not delay disease progression long enough to be clinically meaningful
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Makena’s Accelerated Approval Will Hang In Balance At US FDA Panel Meeting In October
Advisory committee will re-evaluate the continued marketing of AMAG Pharmaceuticals’ preterm birth drug after a failed confirmatory study; the last time an advisory committee weighed in on the future of an accelerated approval drug was for Avastin's breast cancer claim.
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.
Quality-Of-Life Data Take On Added Significance With Avastin Debate
Among the many lessons that cancer drug sponsors should take away from the Avastin proceedings is that if they hope to secure approval on the basis of a progression-free survival endpoint, in certain settings, they need to bolster that data with quality-of-life assessments.