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Mylotarg, Event-Free Survival Endpoint Both Get FDA Panel Endorsement

 
• By Michael Cipriano

Oncologic Drugs Advisory Committee votes 6-1 that benefits of Pfizer's Mylotarg outweigh risks, positioning drug for return to market after being withdrawn in 2010; vote could also open door for future acute myeloid leukemia products to use event-free survival as endpoint.

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The US FDA's Oncologic Drugs Advisory Committee (ODAC) voted 6-1 that Pfizer Inc.'s fractionated dose of its acute myeloid leukemia (AML) drug Mylotarg (gemtuzumab ozogamicin) demonstrates a favorable risk/benefit profile, in a decision that boosts the drug's prospects for full approval and also moves forward the use of event-free survival (EFS) as an efficacy endpoint.

Panelists at the July 11 meeting lauded the EFS endpoint as clinically meaningful, despite FDA's normal standard of overall survival (OS) as an endpoint for AML drugs

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