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ODAC Looks Beyond Dacogen Study’s Statistical Failure, But Still Finds Little Support For New Use

 
• By Sue Sutter

In evaluating a new leukemia indication for Eisai’s Dacogen, the Oncologic Drugs Advisory Committee and FDA reviewers showed they are willing to look beyond a missed efficacy endpoint, but only if the supportive evidence of benefit is really solid. Ten of 14 committee members ultimately concluded that decitabine did not have a favorable risk-benefit profile for elderly AML patients.

Advisory committees and FDA review divisions are willing to look beyond a missed efficacy endpoint and a bad p-value, particularly in a rare disease with a high unmet medical need, but only if the sponsor’s supportive evidence of benefit is really solid and consistent.

That was the message from the Oncologic Drugs Advisory Committee’s Feb. 9 review of a new leukemia indication for Eisai Inc.’s Dacogen (decitabine).

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