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votes 6-1 that benefits of Pfizer's Mylotarg outweigh risks, positioning drug for return to market after being withdrawn in 2010; vote could also open door for future acute myeloid leukemia products to use event-free survival as endpoint.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

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