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Avastin Hearing: Genentech, CDER Dispute Relevance Of Second-Line Breast Cancer Data

This article was originally published in The Pink Sheet Daily

Executive Summary

The parties disagree on whether breast cancer studies conducted outside the first-line setting are relevant to CDER's proposed withdrawal of Avastin's accelerated approval for first-line use.

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An Avastin Loophole: Hamburg Could Decide To Retain Approval During Confirmatory Trial

Even if the commissioner determines the grounds for withdrawing Avastin's accelerated approval in breast cancer have been met, she could decide to retain the claim while Genentech conducts additional confirmatory trials, the hearing notice explains.

An Avastin Loophole: Hamburg Could Decide To Retain Approval During Confirmatory Trial

Even if the commissioner determines the grounds for withdrawing Avastin's accelerated approval in breast cancer have been met, she could decide to retain the claim while Genentech conducts additional confirmatory trials, the hearing notice explains.

Avastin Hearing's Deadline For Written Submissions Is Indefinitely Delayed

Presiding Officer Karen Midthun postpones the submission deadline for written summaries of arguments by Genentech and CDER until one week after the formal hearing notice is issued, although it remains unclear when that will occur.

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