Tecentriq approval on safer ground after FDA panel vote

28 April 2021

While the US regulator has been taking a hard look at Accelerated Approvals which lack confirmatory data, Tecentriq (atezolizumab) appears set to retain its approval in breast cancer at least.

The Oncologic Drugs Advisory Committee (ODAC) voted to maintain the decision on the basis of the clinically-meaningful benefit shown by the IMpassion130 study.

This is despite data from the IMpassion131 study failing to meet its primary endpoint on progression-free survival.

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