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New Avastin Breast Cancer Study Proposal Not Enough To Save Current Claim, ODAC Concludes

This article was originally published in The Pink Sheet Daily

Executive Summary

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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AMAG Open To Another Makena Trial, But Also Appears Ready To Challenge Any Withdrawal Request

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.

Makena Withdrawal Dilemma: Advisory Cmte. Split Offers No Clear Direction For US FDA

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.

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.

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