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Clovis' Rociletinib Facing Three-Year Delay If FDA Follows Panel's Lead

 
• By Sue Sutter

Lung cancer drug gets thumbs down for accelerated approval from advisory committee, meaning FDA's thumbs up might have to wait for results from 900-patient confirmatory trial, which some panelists said should be redesigned to provide more clarity around dosing.

FDA should await results from a randomized, confirmatory trial before approving Clovis Oncology Inc.'s lung cancer drug Xegafri (rociletinib), even though it's unclear how informative the ongoing study will be as to the tyrosine kinase inhibitor's appropriate dose, advisory committee members said April 12.

The Oncologic Drugs Advisory Committee voted 12-1 that results from the ongoing TIGER-3 trial should be submitted before FDA makes a regulatory decision on rociletinib

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