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Ambit Biosciences Provides Regulatory Update Following FDA Meeting Regarding Quizartinib (AC220)
Date:12/3/2013

e">Michael A. Martino, President and CEO of Ambit. "We believe that our data demonstrates the clinical value and benefit of quizartinib for patients in an area of clear and high unmet medical need.  We look forward to presenting our data at ASH next week and anticipate a high level of clinical enthusiasm."

Data from quizartinib studies will be presented at the ASH 55th Annual Meeting at the Ernest Morial Convention Center in New Orleans, LA on December 9, 2013. 

Oral Presentations:

Results of Phase 2 Randomized, Open-Label, Study of Lower Doses of Quizartinib in Subjects with FLT3-ITD Positive Relapsed Acute Myeloid Leukemia (AML): The purpose of this study is to assess the efficacy and safety of lower doses of quizartinib in the treatment of patients 18-years or older with relapsed/refractory FLT3 ITD positive AML to further improve the benefit:risk assessment of quizartinib. The data will be presented by Dr. Jorge Cortes at 3:00 pm CT on Monday, December 9, in the La Nouvelle Ballroom C.

Quizartinib Can Be Safely Combined With Conventional Chemotherapy In Older Patients With Newly Diagnosed Acute Myeloid Leukemia: Experience From The AML Pilot Trial: This is the first presentation of quizartinib use in combination with chemotherapy in newly diagnosed older AML patients, testing the feasibility and dose which could be given sequentially following conventional chemotherapy in patients over the age of 60 years. The data will be presented by Dr. Alan Burnett at 5:15 pm CT on Monday, December 9, in the La Nouvelle Ballroom C.

Results of Phase 1 Study of Quizartinib In Combination with Induction and Consolidation Chemotherapy in Younger Patients with Newly Diagnosed Acute Myeloid Leukemia: This dose escalation study is the first to report data on quizartinib in combination with standard indu
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