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Keytruda's Broad Confirmatory Trials Suggest Evolution Of US FDA’s Accelerated Approval Model

 
• By Michael Cipriano

FDA’s most recent accelerated approvals for Merck’s Keytruda call for confirmatory trials in a broader patient population than the approved indications, in the latest example of FDA’s growing comfort with multi-purpose confirmatory trials in the PD-1/PD-L1 inhibitor space.

The US FDA granted accelerated approval to Merck & Co. Inc.'s PD-1 inhibitor Keytruda on June 13 for a new indication in refractory primary mediastinal large B-cell lymphoma (PMBCL). But the confirmatory trial spelled out in the approval letter is more familiar: the ongoing Phase III KEYNOTE-204 trial, which is also serving as the confirmatory trial for an earlier Keytruda accelerated approval in refractory classic non-Hodgkin lymphoma.

The multiple-use confirmatory trial is becoming a more common sight in the fast-growing immuno-oncology space, and another example of the regulatory flexibility that FDA has

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