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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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US Accelerated Approval: As Makena Withdrawal Hearing Looms, A Look Back At The Avastin Experience

With the public hearing on Covis’ drug for preterm birth prevention expected in 2022, the Pink Sheet talked to several former FDA officials and advisory committee members about their experiences at the 2011 hearing on withdrawal of Avastin’s accelerated approval for breast cancer.

Makena Follows Avastin’s Path With US FDA Hearing On Accelerated Approval Withdrawal

Chief scientist Denise Hinton will decide the fate of Covis’ preterm birth prevention drug because acting commissioner Janet Woodcock has recused herself; CBER deputy director Celia Witten is tapped to serve as presiding officer at the hearing, which will be only the second of its kind under accelerated approval regulations.

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.

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