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Priority review from FDA and Marketing Authorization Application from EMA granted for AbbVie's Venetoclax, the First Potential BCL-2 Inhibitor for Chronic Lymphocytic Leukemia. It's NDA has been accepted by FDA and EMA

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Management Comment "The FDA acceptance and EMA validation of AbbVie's Venetoclax submissions mark a major step forward as we work to become a global leader in oncology, providing new therapies for patients with cancer," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "Patients are always our number one priority and we accelerated our efforts to bring venetoclax, the first BCL-2 inhibitor, to patients with CLL in need of new therapies, including those with 17p deletion who typically have a poor prognosis."
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Jan 12, 2016
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Related Keywords Venetoclax, Bcl-2 Inhibitor, Chronic Lymphocytic Leukemia, Tp53 Mutation., 17p Deletion, B-cell Lymphoma-2, Breakthrough Therapy Designation