New Avastin Breast Cancer Study Proposal Not Enough To Save Current Claim, ODAC Concludes
This article was originally published in The Pink Sheet Daily
FDA's Oncologic Drugs Advisory Committee votes 6-0 for withdrawal of bevacizumab's accelerated approval for first-line metastatic breast cancer, despite Genentech's argument that the indication should be maintained while it conducts another confirmatory trial.
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CEO William Heiden reaffirms commitment to preterm birth drug and suggests AMAG would seek a hearing under the accelerated approval regulations if the US FDA were to request withdrawal; another placebo-controlled confirmatory trial may be possible in European and South American countries, company says.
Nine of 16 advisory committee members favored withdrawal of AMAG’s preterm birth drug because substantial evidence of efficacy is lacking and clinical benefit has not been confirmed; seven panelists favored keeping the drug on the market but requiring a new trial.
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.