Advisory Committee Questions

1. DISCUSSION: Please discuss whether the results of the OS analysis of Study AC220-007 are persuasive evidence of effectiveness of quizartinib and the reasons for your opinion.

2. DISCUSSION: Please discuss the feasibility and adequacy of:

a) A contra-indication for use with drugs that prolong QT via the complementary IKr channel; and

b) A recommendation for administration of beta-blockers to prevent arrythmias as means to reduce the risk of life-threatening and fatal cardiac events resulting from IKs blockade if quizartinib is marketed.

3. VOTE: Do the results of Study AC220-007 demonstrate that treatment with quizartinib provides for a benefit that outweighs the safety risks for patients with relapsed or refractory FLT3-ITD-positive AML?

Daiichi's AML Drug Quizartinib Heads To ODAC With Host Of Efficacy, Safety Issues

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